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FindA University Ltd Featured Continued Professional Development

Professional Development Programs Worldwide

A database of Continuing Professional Development programs covering ALL subject areas!

Are you looking for a course to further your career? Or perhaps you’re looking to develop the skills of your employees? You’ve come to the right place!

FindCPD.com is a brand new site that brings together professional development courses in all subjects into a single easy-to-search database.

Latest CPD Courses
115733| University of Surrey| DBRG Symposium - Tackling inherited and conformational problems in dogs|

 

Tackling inherited and conformational problems in dogs

 

*********

 

10.30 Registration, tea and coffee

 

10.45 Carol Fowler: Welcome and introduction to Dog Breeding Reform Group (DBRG) and DogBreedHealth

 

11.00 Dr Clare Rusbridge: When bad becomes normal – Tackling welfare problems related to conformation

 

12.00 Professor Sheila Crispin: Ocular problems related to poor head conformation: the wrong kind of skin and excessive amounts of skin

 

12.30 Professor Sheila Crispin:: Ocular problems related to poor head conformation: skull shape, does it matter?

 

13.00 Lunch and networking (Poster Session)

 

14.00 Dr Clare Rusbridge: When bad becomes normal: tackling inherited disease

 

15.00 Discussion (both speakers) chaired by Pete Wedderburn: Final thoughts on inherited and breed-related disease.

 

 

*********

 

 

Talks Summaries

 

When Bad Becomes Normal – Welfare problems related to conformation

With an emphasis on neurological problems such as Chiari-like malformation, brachycephaly, syringomyelia, vertebral malformations in screw tailed breeds, and Wobbler’s syndrome, Clare Rusbridge discusses how selection for certain conformation may increase risk of disease and opens discussion on how they could be addressed.

 

Ocular problems related to poor head conformation: the wrong kind of skin and excessive amounts of skin

With the exception of known inherited diseases such as hereditary cutaneous hyaluronosis (HCH), the reasons for poor head conformation are complex and do not follow patterns of Mendelian inheritance. Sheila will argue that breed-specific standards are fine, provided that those standards are not causing, or perpetuating, conformational abnormalities that have health and welfare implications.

 

Tackling ocular problems related to poor head conformation: skull shape, does it matter?

What happens when we select for characteristics that change the shape of the dog’s skull? There are more than 400 documented breeds worldwide and their craniofacial morphological diversity is astounding, but not necessarily synonymous with good health. Sheila discusses the adverse impact that skull shape can have on a dog’s quality of life, with particular emphasis on the ocular problems associated with brachycephaly.

 

When Bad Becomes Normal: tackling inherited disease

With an emphasis on neurological problems such as Lafora’s disease, degenerative myelopathy, epilepsy, and inherited susceptibility to immune-mediated disease and cancer, Clare Rusbridge discusses how challenging it can be to avoid genetic disease or disease susceptibility and opens discussion on how to tackle inherited disorders in a breed.

 

Register here:  surrey.ac.uk/CPD/DBRGsymposium2017

Cost per person: £45
Vet nurses/ Students: £10

 

General enquiries to:

Julia Gerhold,
Professional Development Manager

e: [email protected]

115732| University of Surrey| Challenging Chickens CPD – Practical backyard poultry medicine|

Would you like to be more confident examining, diagnosing and treating the common poultry ailments & diseases presented in your practice?

Date:                                    Wednesday, 30th August 2017

Location:                              School of Veterinary Medicine, University of Surrey, Guildford, UK

Costs:                                   Early-bird rate: £225 (available until 31st July)

Prerequisites:
This 1-day practical course is open to veterinary surgeons.  It is ideal for those who have little or no experience with poultry.

Course Description:
This course aims to give you the confidence to treat poultry, utilising and building on your existing skills as a clinician and surgeon. After completing it, you will also be able to recognise the depth of knowledge of the poultry owner so that you can work together to manage and improve their flock health.

Topics covered:

  • Poultry anatomy
  • Basic husbandry for backyard poultry
  • Clinical examination and diagnostic sample collection
  • How to safely anaesthetise a chicken
  • Common diseases of backyard poultry
  • Prevention and therapeutic options for backyard poultry
  • Recognition of notifiable and zoonotic diseases, the biosecurity measures that can be taken, treatment with products available in the practice, prevention whilst remembering the limitations imposed because they may be producing food for human consumption
  • Appropriate antimicrobial prescription.

Bring your stethoscope as you will have the opportunity to handle and clinically examine different breeds of poultry.

You will also have the opportunity to undertake a basic post mortem examination to both refresh your knowledge of the anatomy of the fowl and discover the benefits that these investigations can give for flock health and welfare.

This will be a highly interactive course with individual participation being key.

Facilitators: 
Paula Guley is the Programme Secretary for Salisbury Poultry Club and has many years’ experience keeping a variety of poultry. She will provide the background on feeding, management, housing and breeding based on her daily routine of looking after peafowl, geese, pheasants, large fowl, bantams, ducks, guinea fowl and quail.

David Parsons B.Vet.Med Cert.PMP M.Sc N.Sch. has over 40 years of experience working with poultry. Since 1985, he has run his own practice providing poultry related veterinary services to chicken, duck, gamebird, pigeon and turkey clients, veterinary practices, pharmaceutical industry.  He is an Honorary Lecturer at the University of Bristol, has taught pigeon health and management at Liverpool University, is a lecturer on the Institute of Animal Health and Nottingham University Poultry Disease course. David is also a member of the British and European Veterinary Poultry Associations, a Nuffield Scholar and is currently working with Estcourt Vets in Devizes where he runs a Chicken Chat monthly for clients.

Henrietta Kodilinye-Sims (Henri) PgDipVEPH BVetMed MRCVS began her career in mixed practice before moving to commercial poultry to follow her interests inspired by her pet chickens. She was awarded the British Poultry Council scholarship for research into broiler welfare indicators and was responsible for running CPD courses for farmers. She now leads the production animal teaching at Surrey University Veterinary School, specialising in poultry.

Henri and David will discuss and demonstrate the clinical examination and diagnostic sampling techniques.

 

Date:                                     Wednesday, 30th August 2017

Location:                              School of Veterinary Medicine, University of Surrey, Guildford, UK

Costs:

  - Early-bird:                            £225 (available until 31st July)

  - Standard:                            £295 (Partner & Group Discounts are available, please e-mail for more nformation)                                      

CPD hours:                           6

Contact:                                Julia Gerhold

Telephone:                           01483 689526

E-mail:                                   [email protected]

115730| Multiple Locations| FDA FSMA Rules & Planning Valid Preventive Food Safety Controls 2017|

 

Course "Preparing to Comply with the New FDA FSMA Rules: Planning Valid Preventive Food Safety Controls" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

Upon completing this course participants will leave with a preliminary preventive control implementation plan and will:

  • Understand US FDA final rules for the Preventive Controls for Human and Animal Foods
  • Define and review your current system to identify gaps in your preventive controls planning.
  • Be able to develop and implement a valid preventive control company food safety plan to close any gaps
  • Write and implement appropriate procedures.
  • Know your requirements for control over your supply chain
  • Be able to plan and implement HARPC
  • Be able to perform environmental monitoring
  • Know how cross contamination can impact your preventive control plan
  • Know the difference between validation and verification
  • Understand and be able to use statistical process controls basics
  • Be able to plan and implement a team approach to preventive controls
  • Be able to help your food importers to jump through FDA hoops
  • Develop a system to risk rank your suppliers
  • Have a plan in hand that will pass any validation check for preventive controls
  • Understand some of the technology and costs that can help you establish preventive controls
  • Prove that your system actually prevents food safety problems
  • Be able to document and report results to upper management, external food safety auditors and FDA auditors
  • Save your company money Establish simple, low cost complete data collection and reporting systems.
  • Establish teambuilding between food safety and quality personnel to develop and implement changes to your current system
  • Understand food safety, security and recall responsibilities in light of cargo theft, adulteration and temperature failures
  • Learn how to use your system to get some ROI and improve your marketing position
  • Review current and future technologies designed to improve and simplify data collection
  • Establish a completely documented system

 

Why should you attend:

 

Validation of preventive controls is where the rubber meets the road in terms of prevention. You can develop a food safety plan, implement the plan and verify the plan, but if your data does not prove that you are actually preventing food safety problems, the plan is not considered valid and your overall food safety effort will fail audits.

According to the FDA all food facilities "must monitor their controls, conduct verification activities, provide hard data to validate that the controls are effective, take appropriate corrective actions, and maintain records documenting these actions". This training session will present a practical approach to provide you and your team members with needed understanding and tools and a basic strategy for designing, implementing and validating preventive process controls.

You will develop a basic plan during this training and have it checked by the instructor.

Regardless of your ability to understand or validate processes, process validation is now a legal requirement and you cannot wait for the FDA to develop their ability to assist your company

 

Areas Covered in the Session:

 

  • Preventive Control System Planning Requirements and Goals
  • Review of the FDA's FSMA Overall Rules
  • Review of final rules for the preventive control of human and animal foods
    • Validation
    • Environmental Monitoring (Sampling/Test/Labs/Data)
    • Supply Chain Controls (Including imports)
    • cGMP
  • Hazards and Adulteration
  • Prevention versus Corrective Action
  • Cross Contamination through Supply Chains
  • Food Safety and Quality Planning (HARPC)
  • Packaging
  • Teams and Teamwork
  • Continuous Improvement
  • Measurement, Repeatability, Reliability, Calibration
  • Statistical Process Control (SPC)
  • Data, logs, forms and electronic record keeping
  • Recall and Traceability
  • Return on investment (ROI) and marketing advantages
  • Integrated Food Safety Systems (Government vs Business needs)
  • Transportation Processes
  • Customers

 

Who Will Benefit:

 

  • Mandatory for upper level management needing to understand impact of laws relating to food safety program validation
  • Legal team members focused on food safety
  • Food quality and safety personnel
  • Food safety leads and implementation team members
  • Maintenance operations personnel
  • Food facility personnel
  • Food importers whose food will be consumed in the U.S.
  • Food security personnel
  • Recall specialists
  • Company sales and marketing personnel whose customers demand sanitary and temperature controlled distribution and transportation processes

 

 

Agenda:

 

Day 1 Schedule

 

Lecture 1:

  • Preventive Control System Planning Requirements and Goals Preventive Control System Planning Requirements and Goals
  • Review of the FDA's FSMA Overall Rules
  • Review of final rules for the preventive control of human and animal foods
  • Validation

Lecture 2:

  • Environmental Monitoring (Sampling/Test/Labs/Data)
  • Supply Chain Controls (including Imported Foods)
  • c/GMP

Lecture 3:

  • Hazards and Adulteration
  • Prevention versus Corrective Action
  • Cross Contamination through Supply Chains

Lecture 4: System Planning Activities

Day 2 Schedule

Lecture 1:

  • HARPC Food Safety and Quality Planning
  • Packaging

Lecture 2:

  • Teams, Teamwork and Continuous Improvement
  • Measurement, repeatability, Reliability, Calibration
  • Statistical Process Control

Lecture 3:

  • Data, logs, forms and electronic record keeping
  • Recall and Traceability
  • ROI
  • Integrated Food Safety Systems (Government versus Business)

Lecture 4:

  • Transportation Processes
  • Customers
  • System Planning

 

Speaker

John Ryan

President , TransCert , QualityInFoodSafety , RyanSystems 

Dr. John Ryan's quality system career has spanned the manufacturing, food, transportation and Internet industries over the past 30 years. He has worked and lived extensively throughout Asia and the U.S. at the corporate and facility levels for large and small companies as a turn-around specialist. His clients have included Seagate Technology, Read-Rite, Destron IDI, Intel, and GSS-Array. He has consulted, taught at the university graduate level, and is a retired quality assurance administrator from the Hawaii State Department of Agriculture. He holds a Ph.D. and has been involved in the quality profession for over 30 years on an international basis and in a variety of industries. He designed and piloted the United States first RFID enabled farm to retail traceability system in the nation while working with Motorola, Lowry Systems and other well-known industry companies. He has published over forty papers on quality systems and has recently published a book for Elsevier Press entitled "Guide to Food Safety and Quality During Transportation: Controls, Standards and Practices". He previously published "The Quality Team Concept in Total Quality Control" with the American Society for Quality. He began Ryan Systems over ten years ago.

Ryan Systems works with some of the world's leading equipment, hardware, software, training and integration companies in the business. We are closely connected with food safety and other audit activities and can begin an initial assessment of your capabilities and needs. Ryan Systems works with partners whose products have proven themselves to be positioned for future quality system needs.

 

Location: San Diego, CA Date:  September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  WILL BE ANNOUNCED SOON, San Diego, CA

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,295.00 From August 11 to September 12, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

 

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901120SEMINAR?findcpd-September-2017-SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

115731| Multiple Locations| FDA FSMA Rules & Planning Valid Preventive Food Safety Controls 2017|

 

Course "Preparing to Comply with the New FDA FSMA Rules: Planning Valid Preventive Food Safety Controls" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

Upon completing this course participants will leave with a preliminary preventive control implementation plan and will:

  • Understand US FDA final rules for the Preventive Controls for Human and Animal Foods
  • Define and review your current system to identify gaps in your preventive controls planning.
  • Be able to develop and implement a valid preventive control company food safety plan to close any gaps
  • Write and implement appropriate procedures.
  • Know your requirements for control over your supply chain
  • Be able to plan and implement HARPC
  • Be able to perform environmental monitoring
  • Know how cross contamination can impact your preventive control plan
  • Know the difference between validation and verification
  • Understand and be able to use statistical process controls basics
  • Be able to plan and implement a team approach to preventive controls
  • Be able to help your food importers to jump through FDA hoops
  • Develop a system to risk rank your suppliers
  • Have a plan in hand that will pass any validation check for preventive controls
  • Understand some of the technology and costs that can help you establish preventive controls
  • Prove that your system actually prevents food safety problems
  • Be able to document and report results to upper management, external food safety auditors and FDA auditors
  • Save your company money Establish simple, low cost complete data collection and reporting systems.
  • Establish teambuilding between food safety and quality personnel to develop and implement changes to your current system
  • Understand food safety, security and recall responsibilities in light of cargo theft, adulteration and temperature failures
  • Learn how to use your system to get some ROI and improve your marketing position
  • Review current and future technologies designed to improve and simplify data collection
  • Establish a completely documented system

 

Why should you attend:

 

Validation of preventive controls is where the rubber meets the road in terms of prevention. You can develop a food safety plan, implement the plan and verify the plan, but if your data does not prove that you are actually preventing food safety problems, the plan is not considered valid and your overall food safety effort will fail audits.

According to the FDA all food facilities "must monitor their controls, conduct verification activities, provide hard data to validate that the controls are effective, take appropriate corrective actions, and maintain records documenting these actions". This training session will present a practical approach to provide you and your team members with needed understanding and tools and a basic strategy for designing, implementing and validating preventive process controls.

You will develop a basic plan during this training and have it checked by the instructor.

Regardless of your ability to understand or validate processes, process validation is now a legal requirement and you cannot wait for the FDA to develop their ability to assist your company

 

Areas Covered in the Session:

 

  • Preventive Control System Planning Requirements and Goals
  • Review of the FDA's FSMA Overall Rules
  • Review of final rules for the preventive control of human and animal foods
    • Validation
    • Environmental Monitoring (Sampling/Test/Labs/Data)
    • Supply Chain Controls (Including imports)
    • cGMP
  • Hazards and Adulteration
  • Prevention versus Corrective Action
  • Cross Contamination through Supply Chains
  • Food Safety and Quality Planning (HARPC)
  • Packaging
  • Teams and Teamwork
  • Continuous Improvement
  • Measurement, Repeatability, Reliability, Calibration
  • Statistical Process Control (SPC)
  • Data, logs, forms and electronic record keeping
  • Recall and Traceability
  • Return on investment (ROI) and marketing advantages
  • Integrated Food Safety Systems (Government vs Business needs)
  • Transportation Processes
  • Customers

 

Who Will Benefit:

 

  • Mandatory for upper level management needing to understand impact of laws relating to food safety program validation
  • Legal team members focused on food safety
  • Food quality and safety personnel
  • Food safety leads and implementation team members
  • Maintenance operations personnel
  • Food facility personnel
  • Food importers whose food will be consumed in the U.S.
  • Food security personnel
  • Recall specialists
  • Company sales and marketing personnel whose customers demand sanitary and temperature controlled distribution and transportation processes

 

 

Agenda:

 

Day 1 Schedule

 

Lecture 1:

  • Preventive Control System Planning Requirements and Goals Preventive Control System Planning Requirements and Goals
  • Review of the FDA's FSMA Overall Rules
  • Review of final rules for the preventive control of human and animal foods
  • Validation

Lecture 2:

  • Environmental Monitoring (Sampling/Test/Labs/Data)
  • Supply Chain Controls (including Imported Foods)
  • c/GMP

Lecture 3:

  • Hazards and Adulteration
  • Prevention versus Corrective Action
  • Cross Contamination through Supply Chains

Lecture 4: System Planning Activities

Day 2 Schedule

Lecture 1:

  • HARPC Food Safety and Quality Planning
  • Packaging

Lecture 2:

  • Teams, Teamwork and Continuous Improvement
  • Measurement, repeatability, Reliability, Calibration
  • Statistical Process Control

Lecture 3:

  • Data, logs, forms and electronic record keeping
  • Recall and Traceability
  • ROI
  • Integrated Food Safety Systems (Government versus Business)

Lecture 4:

  • Transportation Processes
  • Customers
  • System Planning

 

Speaker

John Ryan

President , TransCert , QualityInFoodSafety , RyanSystems 

Dr. John Ryan's quality system career has spanned the manufacturing, food, transportation and Internet industries over the past 30 years. He has worked and lived extensively throughout Asia and the U.S. at the corporate and facility levels for large and small companies as a turn-around specialist. His clients have included Seagate Technology, Read-Rite, Destron IDI, Intel, and GSS-Array. He has consulted, taught at the university graduate level, and is a retired quality assurance administrator from the Hawaii State Department of Agriculture. He holds a Ph.D. and has been involved in the quality profession for over 30 years on an international basis and in a variety of industries. He designed and piloted the United States first RFID enabled farm to retail traceability system in the nation while working with Motorola, Lowry Systems and other well-known industry companies. He has published over forty papers on quality systems and has recently published a book for Elsevier Press entitled "Guide to Food Safety and Quality During Transportation: Controls, Standards and Practices". He previously published "The Quality Team Concept in Total Quality Control" with the American Society for Quality. He began Ryan Systems over ten years ago.

Ryan Systems works with some of the world's leading equipment, hardware, software, training and integration companies in the business. We are closely connected with food safety and other audit activities and can begin an initial assessment of your capabilities and needs. Ryan Systems works with partners whose products have proven themselves to be positioned for future quality system needs.

 

Location: San Diego, CA Date:  September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  WILL BE ANNOUNCED SOON, San Diego, CA

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,295.00 From August 11 to September 12, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

 

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901120SEMINAR?findcpd-September-2017-SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

115728| Multiple Locations| Supplier Management in FDA- and ISO-regulated Industry 2017|

Course "Supplier Management in FDA- and ISO-regulated Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance. Many companies can spend significantly less time and money, and still be in control of their suppliers and in compliance with the regulations. This class will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation. The QSR/ISO requirements for supplier assessment will be defined as well. Attention will be paid to inclusion of risk management in across both supplier qualification and assessment, implementation of which will allow your company to devote value-added resources to these efforts. Significant time will be spent on discussion of the topic of supplier nonconformance, including how and when to issue the dreaded Supplier Corrective Action Request. Your supplier nonconformance handling process must be nonconfrontational, or even better, collaborative. If your company is too demanding of your suppliers, you risk alienating them or even worse losing them - try explaining that to your supply chain folks.

 

Why should you attend

 

Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meets all required regulations and guidance documents, especially for outsourced processes such as contract manufacturing, sterilization and testing, and also for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that you have sufficient control over your suppliers to assure auditors and regulatory agencies that your product is safe and meets all your requirements? Your supplier management program can be in compliance, but is it cost effective? If not, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If your company is too demanding of your suppliers, you risk alienating them or even worse losing them - try explaining that to your supply chain folks!

 

Areas Covered in the Session:

 

  • Supplier Selection
    • Review of FDA requirements
    • Review of ISO requirements
    • Types of suppliers that must be qualified
    • Defining critical suppliers
    • Outsourced processes
    • Recommended Practices
    • Documentation requirements
    • Use of Risk Assessment
    • The Quality Agreement
    • Common Pitfalls
  • Supplier Assessment
    • Review of FDA requirements
    • Review of ISO requirements
    • Case Study: A Hypothetical Supplier Assessment
    • Recommended Practices
    • Documentation requirements
    • Use of Risk Assessment
    • Common Pitfalls
  • Supplier Nonconformance
    • Types of supplier nonconformances
      • Best Practices for Notification
      • Best Practices for Handling
      • Trending
      • Evaluation of Supplier Response
      • Tracking effectiveness
    • Supplier Corrective Action Requests
      • Pre-notification?
      • Best Practices for Issuance
      • Followup
      • Evaluation/Acceptance of Supplier Response
      • Tracking effectiveness
  • Workshop: Review of Supplier Responses: Acceptable or UNacceptable?

 

Who Will Benefit:

 

This webinar will provide valuable assistance to all regulated companies that are interested in implementing and maintaining a supplier management program that is both compliant and cost-efficient. The employees who will benefit include:

  • Supply chain management
  • Buyers
  • Purchasing management
  • CAPA Coordinators
  • Regulatory management
  • QA management
  • Executive management
  • Internal auditors

 

 

Agenda:

 

 

Day 1 Schedule

 

Lecture 1: Introduction
Supplier Selection

  • Review of FDA requirements
  • Review of ISO requirements
  • Types of suppliers that must be qualified
  • Defining critical suppliers
  • Outsourced processes

Lecture 2: 
Supplier Selection (cont)

  • Recommended Practices
  • Documentation requirements
  • Use of Risk Assessment
  • The Quality Agreement
  • Common Pitfalls

Lecture 3: 
Supplier Assessment

  • Review of FDA requirements
  • Review of ISO requirements
  • Case Study: A Hypothetical Supplier Assessment
  • Recommended Practices

Lecture 4: 
Supplier Assessment (cont)

  • Documentation requirements
  • Use of Risk Assessment
  • Common Pitfalls

 

Day 2 Schedule

 

Lecture 1: 
Supplier Nonconformance

  • Types of supplier nonconformances
    • Best Practices for Handling
    • Best Practices for Notification
    • Trending
    • Evaluation of Supplier Response
    • Tracking effectiveness

Lecture 2: 
Supplier Nonconformance (cont)

  • Supplier Corrective Action Requests
    • Pre-notification?
    • Best Practices for Issuance
    • Followup
    • Evaluation/Acceptance of Supplier Response
    • Tracking effectiveness

Lecture 3: 
Workshop

  • Acceptability of Supplier Responses

Lecture 4: 
Q&A - Conclusion

 

Speaker

Jeff Kasoff

Director of Regulatory Affairs, Life-Tech, Inc 

Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS , his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

 

Location: San Diego, CA Date:  September 14th & 15th, 2017 and Time: 9:00 AM to 4:00 PM

Venue:  DoubleTree by Hilton San Diego Downtown   1646 Front St, San Diego, CA 92101, USA

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,295.00 From August 11 to September 12, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

 

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901002SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

115729| Multiple Locations| Supplier Management in FDA- and ISO-regulated Industry 2017|

Course "Supplier Management in FDA- and ISO-regulated Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance. Many companies can spend significantly less time and money, and still be in control of their suppliers and in compliance with the regulations. This class will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation. The QSR/ISO requirements for supplier assessment will be defined as well. Attention will be paid to inclusion of risk management in across both supplier qualification and assessment, implementation of which will allow your company to devote value-added resources to these efforts. Significant time will be spent on discussion of the topic of supplier nonconformance, including how and when to issue the dreaded Supplier Corrective Action Request. Your supplier nonconformance handling process must be nonconfrontational, or even better, collaborative. If your company is too demanding of your suppliers, you risk alienating them or even worse losing them - try explaining that to your supply chain folks.

 

Why should you attend

 

Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meets all required regulations and guidance documents, especially for outsourced processes such as contract manufacturing, sterilization and testing, and also for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that you have sufficient control over your suppliers to assure auditors and regulatory agencies that your product is safe and meets all your requirements? Your supplier management program can be in compliance, but is it cost effective? If not, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If your company is too demanding of your suppliers, you risk alienating them or even worse losing them - try explaining that to your supply chain folks!

 

Areas Covered in the Session:

 

  • Supplier Selection
    • Review of FDA requirements
    • Review of ISO requirements
    • Types of suppliers that must be qualified
    • Defining critical suppliers
    • Outsourced processes
    • Recommended Practices
    • Documentation requirements
    • Use of Risk Assessment
    • The Quality Agreement
    • Common Pitfalls
  • Supplier Assessment
    • Review of FDA requirements
    • Review of ISO requirements
    • Case Study: A Hypothetical Supplier Assessment
    • Recommended Practices
    • Documentation requirements
    • Use of Risk Assessment
    • Common Pitfalls
  • Supplier Nonconformance
    • Types of supplier nonconformances
      • Best Practices for Notification
      • Best Practices for Handling
      • Trending
      • Evaluation of Supplier Response
      • Tracking effectiveness
    • Supplier Corrective Action Requests
      • Pre-notification?
      • Best Practices for Issuance
      • Followup
      • Evaluation/Acceptance of Supplier Response
      • Tracking effectiveness
  • Workshop: Review of Supplier Responses: Acceptable or UNacceptable?

 

Who Will Benefit:

 

This webinar will provide valuable assistance to all regulated companies that are interested in implementing and maintaining a supplier management program that is both compliant and cost-efficient. The employees who will benefit include:

  • Supply chain management
  • Buyers
  • Purchasing management
  • CAPA Coordinators
  • Regulatory management
  • QA management
  • Executive management
  • Internal auditors

 

 

Agenda:

 

 

Day 1 Schedule

 

Lecture 1: Introduction
Supplier Selection

  • Review of FDA requirements
  • Review of ISO requirements
  • Types of suppliers that must be qualified
  • Defining critical suppliers
  • Outsourced processes

Lecture 2: 
Supplier Selection (cont)

  • Recommended Practices
  • Documentation requirements
  • Use of Risk Assessment
  • The Quality Agreement
  • Common Pitfalls

Lecture 3: 
Supplier Assessment

  • Review of FDA requirements
  • Review of ISO requirements
  • Case Study: A Hypothetical Supplier Assessment
  • Recommended Practices

Lecture 4: 
Supplier Assessment (cont)

  • Documentation requirements
  • Use of Risk Assessment
  • Common Pitfalls

 

Day 2 Schedule

 

Lecture 1: 
Supplier Nonconformance

  • Types of supplier nonconformances
    • Best Practices for Handling
    • Best Practices for Notification
    • Trending
    • Evaluation of Supplier Response
    • Tracking effectiveness

Lecture 2: 
Supplier Nonconformance (cont)

  • Supplier Corrective Action Requests
    • Pre-notification?
    • Best Practices for Issuance
    • Followup
    • Evaluation/Acceptance of Supplier Response
    • Tracking effectiveness

Lecture 3: 
Workshop

  • Acceptability of Supplier Responses

Lecture 4: 
Q&A - Conclusion

 

Speaker

Jeff Kasoff

Director of Regulatory Affairs, Life-Tech, Inc 

Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS , his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

 

Location: San Diego, CA Date:  September 14th & 15th, 2017 and Time: 9:00 AM to 4:00 PM

Venue:  DoubleTree by Hilton San Diego Downtown   1646 Front St, San Diego, CA 92101, USA

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,295.00 From August 11 to September 12, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

 

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901002SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

115726| Multiple Locations| Microbial Control, Monitoring, Validation and Troubleshooting 2017|

 

Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don't work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn't recur.

 

Why you should attend:

 

Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it.

 

Who Will Benefit:

 

This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the "true" whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are:

  • Microbiology Laboratory supervisors and analysts responsible for water sampling and testing
  • Quality Assurance personnel responsible for water system deviation management and change control
  • Regulatory and Compliance professionals responsible for FDA interactions
  • Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation
  • Facility Engineers responsible for water system design or renovation
  • Validation personnel for water system qualification
  • Change Control personnel involved in water system changes and repairs
  • Production Managers involved with water system use for manufacturing and cleaning
  • Laboratory Managers and Supervisors responsible for lab water systems and other water sources

 

 

Agenda:

 

 

Day 1 Schedule

 

Lecture 1:

What Makes Water Systems Have Microbial Quality Problems

  • Understand biofilm basics and how it develops
  • Understand the impact of biofilm on the commonly used purification unit operations
  • Understand how various commonly used microbial control strategies work (or don't work) to control biofilm development
  • Understand the how, where, and why of microbial monitoring, action levels, etc.
  • Debunk a few water system myths
  • Get answers to your own water system questions

Lecture 2:

Successful Sanitization Approaches for Trouble-Free Water Quality

  • Material and construction limitations
  • Continuous vs intermittent sanitization
  • The importance of biofilm removal
  • How sanitants work (or don't work)
  • When to sanitize
  • Troubleshooting sanitization problems

Lecture 3:

Water System Validation by Logic Instead of Tradition

  • Why validate a water system?
  • Basic ground rules for water systems before you validate them
  • Micro Test Method "validation"
  • Minimum validation expectations
  • How to figure out what you should validate
  • What happens after the honeymoon is over
  • Is validation ever really over?
  • Special considerations for lab water systems
  • Are packaged waters a viable option?

Lecture 4:

Implementing Changes to a Validated System

  • Purpose of a Change Control program - a help, not a hindrance
  • When is a change major vs minor, requiring full vs limited re-qualification?
  • What about water use during re-qualifications?
  • FDA validation expectations
  • Reliance on logic and common sense and the disservice of precedent and paradigms
  • Additional useful tips

Lecture 5:

Reducing Water Microbial Excursions & Improving Investigations

  • What are excursions?
  • Water system dilemma: process control or quality control (utility or raw material), or both
  • Intended roles of Alert/Action Levels and Specifications
  • Investigation, necessary and often fruitless
  • Excursion responses and impact
  • Criticality of valves, hoses, & outlet flushing
  • Diagnosing the source of the problem
  • Minimizing unnecessary excursion responses through best practices

Day 2 Schedule

Lecture 6:

Understanding and Controlling Endotoxin

  • Where does endotoxin come from?
  • What are the properties of endotoxin?
  • How do you get rid of it?
  • How do you detect it?
  • What assay controls are used?
  • What are the endotoxin specs for water?
  • How do you control it?

Lecture 7:

Harmonizing vs Optimizing Water Microbial Testing for System Quality Control

  • Water harmonization that has occurred
  • Water Micro TM "Dis-Harmonization"
  • A little about Biofilm
  • Biofilm diversity in water systems
  • Micro TM options and evaluation protocol
  • The good and bad of Micro harmonization
  • Where RMMs can fit in
  • Parting wisdom

Lecture 8:

Microbial Enumeration Issues with High Purity Water Systems

  • Microbial Enumeration Issues with High Purity Water Systems
  • Biofilm enumeration issues (planktonic vs surface)
  • Traditional cultivative approach issues
  • Validation of your test method
  • Alternative TM choices (advantages/disadvantages)
  • Significance of water isolates
  • Sampling issues
  • Establishing Alert/Action Levels and Water Specs and defending them to FDA

Lecture 9:

Water System Investigation "How-To's" and Example Case Studies

  • Gathering and assessing existing data and symptoms
  • Considering user opinions
  • Investigation approach elements
  • Recognizing red herrings/false positives
  • Recognizing possible root causes
  • Water system contamination case studies
  • Parting kernels of water system wisdom

Lecture 10:

What USP Does and Doesn't Say about PW, WFI, Pure Steam and Micro Issues

  • PW, WFI, Pure Steam micro specifications?
  • <1231> Starting water issues
  • <1231> Misunderstood issues clarified
  • <1231> Microbiological test issues clarified
  • <1231> Suggested micro test method
  • <1231> Micro Specifications
  • <1231> Alert and Action Levels and max's
  • Recent/Upcoming USP water changes
  • Discrepancies between pharmacopeia's

 

Speaker

Teri C. Soli

Principal Consultant, Soli Pharma Solutions

Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli's career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems.

He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, is the author of USP's Informational Chapter <1231> on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has motivated many audiences and course attendees with practical water system information. He has also authored many articles and chapters in books and industry standards published by PDA and ISPE including chapter authorships in the 2nd ed. ISPE Baseline Guide for Water and Steam Systems, ISPE's Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems, and chapters in several PDA books on pharmaceutical and laboratory water systems and biofilm control. He earned a Ph.D. degree in Microbiology and Immunology from the University of Arizona and M.S. and B.S. degrees in Microbiology from Texas A&M University.

 

Location: Shanghai, China Date:  September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  WILL BE ANNOUNCED SOON, Shanghai, China

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,695.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,695.00 From August 11 to September 09, Regular Price: $1,895.00

Register for 5 attendees   Price: $5,085.00      $8,475.00 You Save: $3,390.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

 

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901124SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

115727| Multiple Locations| Microbial Control, Monitoring, Validation and Troubleshooting 2017|

 

Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don't work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn't recur.

 

Why you should attend:

 

Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it.

 

Who Will Benefit:

 

This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the "true" whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are:

  • Microbiology Laboratory supervisors and analysts responsible for water sampling and testing
  • Quality Assurance personnel responsible for water system deviation management and change control
  • Regulatory and Compliance professionals responsible for FDA interactions
  • Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation
  • Facility Engineers responsible for water system design or renovation
  • Validation personnel for water system qualification
  • Change Control personnel involved in water system changes and repairs
  • Production Managers involved with water system use for manufacturing and cleaning
  • Laboratory Managers and Supervisors responsible for lab water systems and other water sources

 

 

Agenda:

 

 

Day 1 Schedule

 

Lecture 1:

What Makes Water Systems Have Microbial Quality Problems

  • Understand biofilm basics and how it develops
  • Understand the impact of biofilm on the commonly used purification unit operations
  • Understand how various commonly used microbial control strategies work (or don't work) to control biofilm development
  • Understand the how, where, and why of microbial monitoring, action levels, etc.
  • Debunk a few water system myths
  • Get answers to your own water system questions

Lecture 2:

Successful Sanitization Approaches for Trouble-Free Water Quality

  • Material and construction limitations
  • Continuous vs intermittent sanitization
  • The importance of biofilm removal
  • How sanitants work (or don't work)
  • When to sanitize
  • Troubleshooting sanitization problems

Lecture 3:

Water System Validation by Logic Instead of Tradition

  • Why validate a water system?
  • Basic ground rules for water systems before you validate them
  • Micro Test Method "validation"
  • Minimum validation expectations
  • How to figure out what you should validate
  • What happens after the honeymoon is over
  • Is validation ever really over?
  • Special considerations for lab water systems
  • Are packaged waters a viable option?

Lecture 4:

Implementing Changes to a Validated System

  • Purpose of a Change Control program - a help, not a hindrance
  • When is a change major vs minor, requiring full vs limited re-qualification?
  • What about water use during re-qualifications?
  • FDA validation expectations
  • Reliance on logic and common sense and the disservice of precedent and paradigms
  • Additional useful tips

Lecture 5:

Reducing Water Microbial Excursions & Improving Investigations

  • What are excursions?
  • Water system dilemma: process control or quality control (utility or raw material), or both
  • Intended roles of Alert/Action Levels and Specifications
  • Investigation, necessary and often fruitless
  • Excursion responses and impact
  • Criticality of valves, hoses, & outlet flushing
  • Diagnosing the source of the problem
  • Minimizing unnecessary excursion responses through best practices

Day 2 Schedule

Lecture 6:

Understanding and Controlling Endotoxin

  • Where does endotoxin come from?
  • What are the properties of endotoxin?
  • How do you get rid of it?
  • How do you detect it?
  • What assay controls are used?
  • What are the endotoxin specs for water?
  • How do you control it?

Lecture 7:

Harmonizing vs Optimizing Water Microbial Testing for System Quality Control

  • Water harmonization that has occurred
  • Water Micro TM "Dis-Harmonization"
  • A little about Biofilm
  • Biofilm diversity in water systems
  • Micro TM options and evaluation protocol
  • The good and bad of Micro harmonization
  • Where RMMs can fit in
  • Parting wisdom

Lecture 8:

Microbial Enumeration Issues with High Purity Water Systems

  • Microbial Enumeration Issues with High Purity Water Systems
  • Biofilm enumeration issues (planktonic vs surface)
  • Traditional cultivative approach issues
  • Validation of your test method
  • Alternative TM choices (advantages/disadvantages)
  • Significance of water isolates
  • Sampling issues
  • Establishing Alert/Action Levels and Water Specs and defending them to FDA

Lecture 9:

Water System Investigation "How-To's" and Example Case Studies

  • Gathering and assessing existing data and symptoms
  • Considering user opinions
  • Investigation approach elements
  • Recognizing red herrings/false positives
  • Recognizing possible root causes
  • Water system contamination case studies
  • Parting kernels of water system wisdom

Lecture 10:

What USP Does and Doesn't Say about PW, WFI, Pure Steam and Micro Issues

  • PW, WFI, Pure Steam micro specifications?
  • <1231> Starting water issues
  • <1231> Misunderstood issues clarified
  • <1231> Microbiological test issues clarified
  • <1231> Suggested micro test method
  • <1231> Micro Specifications
  • <1231> Alert and Action Levels and max's
  • Recent/Upcoming USP water changes
  • Discrepancies between pharmacopeia's

 

Speaker

Teri C. Soli

Principal Consultant, Soli Pharma Solutions

Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli's career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems.

He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, is the author of USP's Informational Chapter <1231> on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has motivated many audiences and course attendees with practical water system information. He has also authored many articles and chapters in books and industry standards published by PDA and ISPE including chapter authorships in the 2nd ed. ISPE Baseline Guide for Water and Steam Systems, ISPE's Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems, and chapters in several PDA books on pharmaceutical and laboratory water systems and biofilm control. He earned a Ph.D. degree in Microbiology and Immunology from the University of Arizona and M.S. and B.S. degrees in Microbiology from Texas A&M University.

 

Location: Shanghai, China Date:  September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  WILL BE ANNOUNCED SOON, Shanghai, China

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,695.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,695.00 From August 11 to September 09, Regular Price: $1,895.00

Register for 5 attendees   Price: $5,085.00      $8,475.00 You Save: $3,390.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

 

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901124SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

115724| Multiple Locations| Regulatory Requirements and Principles for Cleaning Validation 2017|

Course "Regulatory Requirements and Principles for Cleaning Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.

The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a "Cleaning Validation Master Plan" and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.

 

Why you should attend:

 

Attendance at 2 day seminar will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.

Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful.

 

Areas Covered in the Session:

 

  • Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product
  • Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections
  • Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
  • Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies

 

Who Will Benefit:

 

Attendance at 2 day seminar will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.

Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful.

  • Senior Quality Managers
  • Quality Professionals
  • Production Supervisors
  • Validation Engineers
  • Process Owners
  • Quality Engineers
  • Quality Auditors

 

Agenda:

 

 

Day 1 Schedule 

Lecture 1:

FDA Requirements and Industry Standard Practices

Lecture 2:

How to Develop/Review your Cleaning Procedures and the Adequate Selection of Cleaning Agents and Parameters

Lecture 3:

How to Develop a Cleaning Validation Policy/Program

Lecture 4:

How to Implement a Robust Cleaning Validation Plan

 Day 2 Schedule 

Lecture 1:

Laboratory Issues in Cleaning

Lecture 2:

Microbiological aspects of a cleaning validation program for manufacturing equipment

Lecture 3:

Keys to Cleaning Validation Maintenance - Remaining Compliant

Lecture 4:

Current FDA concerns about validation of cleaning processes

 

Speaker

Joy McElroy

Principle Consultant, Maynard Consulting Company 

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Up John performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.

Now with 12 years experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.

Joy specializes in Equipment Qualification, Cleaning Validation,Sterilization, Environmental Monitoring, and GMP Compliance Auditing

 

Location: San Diego, CA Date: September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  WILL BE ANNOUNCED SOON, San Diego, CA

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,295.00 From August 11 to September 12, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

 

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901170SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

 

115725| Multiple Locations| Regulatory Requirements and Principles for Cleaning Validation 2017|

Course "Regulatory Requirements and Principles for Cleaning Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.

The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a "Cleaning Validation Master Plan" and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.

 

Why you should attend:

 

Attendance at 2 day seminar will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.

Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful.

 

Areas Covered in the Session:

 

  • Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product
  • Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections
  • Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
  • Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies

 

Who Will Benefit:

 

Attendance at 2 day seminar will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.

Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful.

  • Senior Quality Managers
  • Quality Professionals
  • Production Supervisors
  • Validation Engineers
  • Process Owners
  • Quality Engineers
  • Quality Auditors

 

Agenda:

 

 

Day 1 Schedule 

Lecture 1:

FDA Requirements and Industry Standard Practices

Lecture 2:

How to Develop/Review your Cleaning Procedures and the Adequate Selection of Cleaning Agents and Parameters

Lecture 3:

How to Develop a Cleaning Validation Policy/Program

Lecture 4:

How to Implement a Robust Cleaning Validation Plan

 Day 2 Schedule 

Lecture 1:

Laboratory Issues in Cleaning

Lecture 2:

Microbiological aspects of a cleaning validation program for manufacturing equipment

Lecture 3:

Keys to Cleaning Validation Maintenance - Remaining Compliant

Lecture 4:

Current FDA concerns about validation of cleaning processes

 

Speaker

Joy McElroy

Principle Consultant, Maynard Consulting Company 

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Up John performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.

Now with 12 years experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.

Joy specializes in Equipment Qualification, Cleaning Validation,Sterilization, Environmental Monitoring, and GMP Compliance Auditing

 

Location: San Diego, CA Date: September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  WILL BE ANNOUNCED SOON, San Diego, CA

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,295.00 From August 11 to September 12, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

 

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901170SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

 

115722| Multiple Locations| The EU General Data Protection Regulation (GDPR) 2017|

 

Course "The EU General Data Protection Regulation (GDPR)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

On 25th May 2018 the EU-GDPR becomes effective, this date has been set to give organisations time to prepare and comply with the regulations. This may seem to be a long way off, but for most organisations there is a lot to be done.

With the escalation of data breaches, the sooner data is safe guarded the better. Often a data breach is not discovered for months, sometimes six months, implementing new policies, security systems, negotiations with suppliers and training people in an organisation will take time. The sooner you start the more time you have to make a good decision on the options you face.

This introductory course will give you an overview of the history of Data Protection within the EU and introduce you to the enhancements and new obligations imposed by the EU GDPR.

 

Why you should attend:

 

Data protection law in the EU is about to undergo the most significant changes since the 1995 EU Data Protection Directive. The new EU General Data Protection Regulation (GDPR) came into effect in May 2016 and you have until May 2018 to become fully compliant. The new law will require significant preparatory work that you should begin now.

Will the EU GDPR apply to my business?

Does your organisation acquire, store, process, distribute, manage, modify or analyse any data which can be used to identify an EU citizen OR does your organisation trade with EU citizens?

If you answered YES, then no matter whether your organisation is based in the EU or elsewhere in the world, then the EU GDPR will apply to your business. Even though the EU-GDPR is an EU regulation, it has a global reach. If an organisation is outside of the EU it MUST still comply IF it handles, stores, manages, or processes EU citizens' personal data.

The new Regulation will impose many legal obligations on organisations that control or process data and will afford new rights to those whose personal data is being held. The financial penalties for non-compliance will be very substantial so it is absolutely vital that your organisation is fully prepared as early as possible.

 

Areas Covered in the Session:

 

  • Key definitions
  • Bands of penalties and range of awards for breaches
  • Timeline to application of GDPR
  • Six data protection principles, lawfulness and consent
  • Sensitive data
  • Rights of data subjects
  • Controllers and processors
  • Data protection by design
  • Securing personal data
  • Reporting data breaches
  • Transferring personal data outside the EU
  • Powers of supervisory authorities
  • Role of the EDPB (European Data Protection Board)

 

Who Will Benefit:

 

  • Directors
  • Company Secretaries
  • Compliance Officers
  • HR Staff
  • IT Admin
  • Any employee with a responsibility for managing data

 

Agenda:

 

 

Day 1 Schedule

 

Lecture 1:

GDPR Context, Definitions and Penalties

  • Determine what type of personal information is subject to the GDPR
  • Determine the organisational and geographic scope of the GDPR
  • Correctly define terms from the GDPR
  • Identify where data subjects have a right to lodge a complaint with respect to data processing

Lecture 2:

GDPR Context, Definitions and Penalties (Cont.)

  • Identify rights of a data subject to compensation
  • Identify the infringements that will be subject to fines of up to 2% of annual turnover
  • Identify the infringements that will be subject to fines of up to 4% of annual turnover
  • Identify the date on which the GDPR comes into force across the EU

Lecture 3:

GDPR Principles

  • the six principles for the processing of personal data
  • how to demonstrate compliance with each of the six principles
  • how controllers can demonstrate compliance
  • lawful grounds for processing data
  • the legal conditions for consent
  • the additional conditions necessary for a child's consent
  • which special categories of data may not be processed
  • the circumstances in which special data may be processed

Lecture 4:

Rights of Data Subjects

  • Identify the tests to respond transparently to data subject requests
  • Identify the requirements on controllers when obtaining personal data
  • Identify actions necessary in respect of personal data not obtained directly from data subjects
  • Identify a data subject's rights of access
  • Identify the grounds that give the right to be forgotten
  • Identify the grounds that give the right to restrict processing
  • Identify a data subject's right to data portability
  • Identify a data subject's right to object to processing

 

Day 2 Schedule

 

Lecture 1:

Controller and Processor

  • Differentiate between controllers and processors
  • Identify requirements on controllers in respect of processing activities
  • Identify how organisations are required to approach data protection by design
  • Identify the requirements in respect of controllers or processors who are not established in the EU
  • Identify the obligations applied to processors

Lecture 2:

Transfers of personal data

  • Identify the principles covering the transfer of personal data outside the EU
  • Identify where the EU posts details of organisations and/or countries that meet its adequacy test
  • Identify the requirements in respect of binding corporate rules

Lecture 3:

Supervisory authorities

  • Identify the powers of supervisory authorities
  • Identify the role of a lead supervisory authority

Lecture 4:

Co-operation and consistency

  • Identify the tasks of the European Data Protection Board (EDPB)
  • Identify how the EDPB ensures consistency of application of the GDPR across the Member States

 

Speaker

Vanessa Cozens

CEO, The GDPR Clinic 

A Chartered Global Management Accountant (CGMA), Vanessa has many years experience working as a financial controller for multi-national businesses.

A holder of the EU GDPR Practitioner (EU GDPR P) qualification which is ISO 17024 accredited and issued by the International Board for IT Governance Qualifications (IBITGQ), she now works with businesses to help them with GDPR compliance and training.

She has vast experience working within senior management teams and has been involved with the establishment and implementation of corporate policies, ensuring that they meet the strict levels of both internal and external corporate standards.

Vanessa is now the CEO of The GDPR Clinic based in the UK and works with businesses to help them with GDPR compliance and training.

 

Location: London, UK Date:  September 12th & 13th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  WILL BE ANNOUNCED SOON  

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,695.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,695.00 From August 11 to September 10, Regular Price: $1,895.00

Register for 5 attendees   Price: $5,085.00      $8,475.00 You Save: $3,390.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901168SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

115723| Multiple Locations| The EU General Data Protection Regulation (GDPR) 2017|

 

Course "The EU General Data Protection Regulation (GDPR)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

On 25th May 2018 the EU-GDPR becomes effective, this date has been set to give organisations time to prepare and comply with the regulations. This may seem to be a long way off, but for most organisations there is a lot to be done.

With the escalation of data breaches, the sooner data is safe guarded the better. Often a data breach is not discovered for months, sometimes six months, implementing new policies, security systems, negotiations with suppliers and training people in an organisation will take time. The sooner you start the more time you have to make a good decision on the options you face.

This introductory course will give you an overview of the history of Data Protection within the EU and introduce you to the enhancements and new obligations imposed by the EU GDPR.

 

Why you should attend:

 

Data protection law in the EU is about to undergo the most significant changes since the 1995 EU Data Protection Directive. The new EU General Data Protection Regulation (GDPR) came into effect in May 2016 and you have until May 2018 to become fully compliant. The new law will require significant preparatory work that you should begin now.

Will the EU GDPR apply to my business?

Does your organisation acquire, store, process, distribute, manage, modify or analyse any data which can be used to identify an EU citizen OR does your organisation trade with EU citizens?

If you answered YES, then no matter whether your organisation is based in the EU or elsewhere in the world, then the EU GDPR will apply to your business. Even though the EU-GDPR is an EU regulation, it has a global reach. If an organisation is outside of the EU it MUST still comply IF it handles, stores, manages, or processes EU citizens' personal data.

The new Regulation will impose many legal obligations on organisations that control or process data and will afford new rights to those whose personal data is being held. The financial penalties for non-compliance will be very substantial so it is absolutely vital that your organisation is fully prepared as early as possible.

 

Areas Covered in the Session:

 

  • Key definitions
  • Bands of penalties and range of awards for breaches
  • Timeline to application of GDPR
  • Six data protection principles, lawfulness and consent
  • Sensitive data
  • Rights of data subjects
  • Controllers and processors
  • Data protection by design
  • Securing personal data
  • Reporting data breaches
  • Transferring personal data outside the EU
  • Powers of supervisory authorities
  • Role of the EDPB (European Data Protection Board)

 

Who Will Benefit:

 

  • Directors
  • Company Secretaries
  • Compliance Officers
  • HR Staff
  • IT Admin
  • Any employee with a responsibility for managing data

 

Agenda:

 

 

Day 1 Schedule

 

Lecture 1:

GDPR Context, Definitions and Penalties

  • Determine what type of personal information is subject to the GDPR
  • Determine the organisational and geographic scope of the GDPR
  • Correctly define terms from the GDPR
  • Identify where data subjects have a right to lodge a complaint with respect to data processing

Lecture 2:

GDPR Context, Definitions and Penalties (Cont.)

  • Identify rights of a data subject to compensation
  • Identify the infringements that will be subject to fines of up to 2% of annual turnover
  • Identify the infringements that will be subject to fines of up to 4% of annual turnover
  • Identify the date on which the GDPR comes into force across the EU

Lecture 3:

GDPR Principles

  • the six principles for the processing of personal data
  • how to demonstrate compliance with each of the six principles
  • how controllers can demonstrate compliance
  • lawful grounds for processing data
  • the legal conditions for consent
  • the additional conditions necessary for a child's consent
  • which special categories of data may not be processed
  • the circumstances in which special data may be processed

Lecture 4:

Rights of Data Subjects

  • Identify the tests to respond transparently to data subject requests
  • Identify the requirements on controllers when obtaining personal data
  • Identify actions necessary in respect of personal data not obtained directly from data subjects
  • Identify a data subject's rights of access
  • Identify the grounds that give the right to be forgotten
  • Identify the grounds that give the right to restrict processing
  • Identify a data subject's right to data portability
  • Identify a data subject's right to object to processing

 

Day 2 Schedule

 

Lecture 1:

Controller and Processor

  • Differentiate between controllers and processors
  • Identify requirements on controllers in respect of processing activities
  • Identify how organisations are required to approach data protection by design
  • Identify the requirements in respect of controllers or processors who are not established in the EU
  • Identify the obligations applied to processors

Lecture 2:

Transfers of personal data

  • Identify the principles covering the transfer of personal data outside the EU
  • Identify where the EU posts details of organisations and/or countries that meet its adequacy test
  • Identify the requirements in respect of binding corporate rules

Lecture 3:

Supervisory authorities

  • Identify the powers of supervisory authorities
  • Identify the role of a lead supervisory authority

Lecture 4:

Co-operation and consistency

  • Identify the tasks of the European Data Protection Board (EDPB)
  • Identify how the EDPB ensures consistency of application of the GDPR across the Member States

 

Speaker

Vanessa Cozens

CEO, The GDPR Clinic 

A Chartered Global Management Accountant (CGMA), Vanessa has many years experience working as a financial controller for multi-national businesses.

A holder of the EU GDPR Practitioner (EU GDPR P) qualification which is ISO 17024 accredited and issued by the International Board for IT Governance Qualifications (IBITGQ), she now works with businesses to help them with GDPR compliance and training.

She has vast experience working within senior management teams and has been involved with the establishment and implementation of corporate policies, ensuring that they meet the strict levels of both internal and external corporate standards.

Vanessa is now the CEO of The GDPR Clinic based in the UK and works with businesses to help them with GDPR compliance and training.

 

Location: London, UK Date:  September 12th & 13th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  WILL BE ANNOUNCED SOON  

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,695.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,695.00 From August 11 to September 10, Regular Price: $1,895.00

Register for 5 attendees   Price: $5,085.00      $8,475.00 You Save: $3,390.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901168SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

115720| Multiple Locations| Validation and Troubleshooting of Pharmaceutical Water Systems 2017|

 

Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don't work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn't recur.

 

Why you should attend:

 

Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it.

 

Who Will Benefit:

 

This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the "true" whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are:

  • Microbiology Laboratory supervisors and analysts responsible for water sampling and testing
  • Quality Assurance personnel responsible for water system deviation management and change control
  • Regulatory and Compliance professionals responsible for FDA interactions
  • Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation
  • Facility Engineers responsible for water system design or renovation
  • Validation personnel for water system qualification
  • Change Control personnel involved in water system changes and repairs
  • Production Managers involved with water system use for manufacturing and cleaning
  • Laboratory Managers and Supervisors responsible for lab water systems and other water sources

 

 

Agenda:

 

 

Day 1 Schedule

 

Lecture 1:

What Makes Water Systems Have Microbial Quality Problems

  • Understand biofilm basics and how it develops
  • Understand the impact of biofilm on the commonly used purification unit operations
  • Understand how various commonly used microbial control strategies work (or don't work) to control biofilm development
  • Understand the how, where, and why of microbial monitoring, action levels, etc.
  • Debunk a few water system myths
  • Get answers to your own water system questions

Lecture 2:

Successful Sanitization Approaches for Trouble-Free Water Quality

  • Material and construction limitations
  • Continuous vs intermittent sanitization
  • The importance of biofilm removal
  • How sanitants work (or don't work)
  • When to sanitize
  • Troubleshooting sanitization problems

Lecture 3:

Water System Validation by Logic Instead of Tradition

  • Why validate a water system?
  • Basic ground rules for water systems before you validate them
  • Micro Test Method "validation"
  • Minimum validation expectations
  • How to figure out what you should validate
  • What happens after the honeymoon is over
  • Is validation ever really over?
  • Special considerations for lab water systems
  • Are packaged waters a viable option?

Lecture 4:

Implementing Changes to a Validated System

  • Purpose of a Change Control program - a help, not a hindrance
  • When is a change major vs minor, requiring full vs limited re-qualification?
  • What about water use during re-qualifications?
  • FDA validation expectations
  • Reliance on logic and common sense and the disservice of precedent and paradigms
  • Additional useful tips

Lecture 5:

Reducing Water Microbial Excursions & Improving Investigations

  • What are excursions?
  • Water system dilemma: process control or quality control (utility or raw material), or both
  • Intended roles of Alert/Action Levels and Specifications
  • Investigation, necessary and often fruitless
  • Excursion responses and impact
  • Criticality of valves, hoses, & outlet flushing
  • Diagnosing the source of the problem
  • Minimizing unnecessary excursion responses through best practices

Day 2 Schedule

Lecture 6:

Understanding and Controlling Endotoxin

  • Where does endotoxin come from?
  • What are the properties of endotoxin?
  • How do you get rid of it?
  • How do you detect it?
  • What assay controls are used?
  • What are the endotoxin specs for water?
  • How do you control it?

Lecture 7:

Harmonizing vs Optimizing Water Microbial Testing for System Quality Control

  • Water harmonization that has occurred
  • Water Micro TM "Dis-Harmonization"
  • A little about Biofilm
  • Biofilm diversity in water systems
  • Micro TM options and evaluation protocol
  • The good and bad of Micro harmonization
  • Where RMMs can fit in
  • Parting wisdom

Lecture 8:

Microbial Enumeration Issues with High Purity Water Systems

  • Microbial Enumeration Issues with High Purity Water Systems
  • Biofilm enumeration issues (planktonic vs surface)
  • Traditional cultivative approach issues
  • Validation of your test method
  • Alternative TM choices (advantages/disadvantages)
  • Significance of water isolates
  • Sampling issues
  • Establishing Alert/Action Levels and Water Specs and defending them to FDA

Lecture 9:

Water System Investigation "How-To's" and Example Case Studies

  • Gathering and assessing existing data and symptoms
  • Considering user opinions
  • Investigation approach elements
  • Recognizing red herrings/false positives
  • Recognizing possible root causes
  • Water system contamination case studies
  • Parting kernels of water system wisdom

Lecture 10:

What USP Does and Doesn't Say about PW, WFI, Pure Steam and Micro Issues

  • PW, WFI, Pure Steam micro specifications?
  • <1231> Starting water issues
  • <1231> Misunderstood issues clarified
  • <1231> Microbiological test issues clarified
  • <1231> Suggested micro test method
  • <1231> Micro Specifications
  • <1231> Alert and Action Levels and max's
  • Recent/Upcoming USP water changes
  • Discrepancies between pharmacopeia's

 

Speaker

Teri C. Soli

Principal Consultant, Soli Pharma Solutions

Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli's career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems.

He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, is the author of USP's Informational Chapter <1231> on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has motivated many audiences and course attendees with practical water system information. He has also authored many articles and chapters in books and industry standards published by PDA and ISPE including chapter authorships in the 2nd ed. ISPE Baseline Guide for Water and Steam Systems, ISPE's Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems, and chapters in several PDA books on pharmaceutical and laboratory water systems and biofilm control. He earned a Ph.D. degree in Microbiology and Immunology from the University of Arizona and M.S. and B.S. degrees in Microbiology from Texas A&M University.

 

Location:  Sydney, Australia Date:  September 11th & 12th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  Hilton Sydney 488 George Street, Sydney, Australia 2000

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,695.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,695.00 From August 11 to September 09, Regular Price: $1,895.00

Register for 5 attendees   Price: $5,085.00      $8,475.00 You Save: $3,390.00 (40%)*

 Register for 10 attendees   Price: $9,322.00      $16,950.00 You Save: $7,628.00 (45%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901122SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

115721| Multiple Locations| Validation and Troubleshooting of Pharmaceutical Water Systems 2017|

 

Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don't work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn't recur.

 

Why you should attend:

 

Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it.

 

Who Will Benefit:

 

This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the "true" whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are:

  • Microbiology Laboratory supervisors and analysts responsible for water sampling and testing
  • Quality Assurance personnel responsible for water system deviation management and change control
  • Regulatory and Compliance professionals responsible for FDA interactions
  • Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation
  • Facility Engineers responsible for water system design or renovation
  • Validation personnel for water system qualification
  • Change Control personnel involved in water system changes and repairs
  • Production Managers involved with water system use for manufacturing and cleaning
  • Laboratory Managers and Supervisors responsible for lab water systems and other water sources

 

 

Agenda:

 

 

Day 1 Schedule

 

Lecture 1:

What Makes Water Systems Have Microbial Quality Problems

  • Understand biofilm basics and how it develops
  • Understand the impact of biofilm on the commonly used purification unit operations
  • Understand how various commonly used microbial control strategies work (or don't work) to control biofilm development
  • Understand the how, where, and why of microbial monitoring, action levels, etc.
  • Debunk a few water system myths
  • Get answers to your own water system questions

Lecture 2:

Successful Sanitization Approaches for Trouble-Free Water Quality

  • Material and construction limitations
  • Continuous vs intermittent sanitization
  • The importance of biofilm removal
  • How sanitants work (or don't work)
  • When to sanitize
  • Troubleshooting sanitization problems

Lecture 3:

Water System Validation by Logic Instead of Tradition

  • Why validate a water system?
  • Basic ground rules for water systems before you validate them
  • Micro Test Method "validation"
  • Minimum validation expectations
  • How to figure out what you should validate
  • What happens after the honeymoon is over
  • Is validation ever really over?
  • Special considerations for lab water systems
  • Are packaged waters a viable option?

Lecture 4:

Implementing Changes to a Validated System

  • Purpose of a Change Control program - a help, not a hindrance
  • When is a change major vs minor, requiring full vs limited re-qualification?
  • What about water use during re-qualifications?
  • FDA validation expectations
  • Reliance on logic and common sense and the disservice of precedent and paradigms
  • Additional useful tips

Lecture 5:

Reducing Water Microbial Excursions & Improving Investigations

  • What are excursions?
  • Water system dilemma: process control or quality control (utility or raw material), or both
  • Intended roles of Alert/Action Levels and Specifications
  • Investigation, necessary and often fruitless
  • Excursion responses and impact
  • Criticality of valves, hoses, & outlet flushing
  • Diagnosing the source of the problem
  • Minimizing unnecessary excursion responses through best practices

Day 2 Schedule

Lecture 6:

Understanding and Controlling Endotoxin

  • Where does endotoxin come from?
  • What are the properties of endotoxin?
  • How do you get rid of it?
  • How do you detect it?
  • What assay controls are used?
  • What are the endotoxin specs for water?
  • How do you control it?

Lecture 7:

Harmonizing vs Optimizing Water Microbial Testing for System Quality Control

  • Water harmonization that has occurred
  • Water Micro TM "Dis-Harmonization"
  • A little about Biofilm
  • Biofilm diversity in water systems
  • Micro TM options and evaluation protocol
  • The good and bad of Micro harmonization
  • Where RMMs can fit in
  • Parting wisdom

Lecture 8:

Microbial Enumeration Issues with High Purity Water Systems

  • Microbial Enumeration Issues with High Purity Water Systems
  • Biofilm enumeration issues (planktonic vs surface)
  • Traditional cultivative approach issues
  • Validation of your test method
  • Alternative TM choices (advantages/disadvantages)
  • Significance of water isolates
  • Sampling issues
  • Establishing Alert/Action Levels and Water Specs and defending them to FDA

Lecture 9:

Water System Investigation "How-To's" and Example Case Studies

  • Gathering and assessing existing data and symptoms
  • Considering user opinions
  • Investigation approach elements
  • Recognizing red herrings/false positives
  • Recognizing possible root causes
  • Water system contamination case studies
  • Parting kernels of water system wisdom

Lecture 10:

What USP Does and Doesn't Say about PW, WFI, Pure Steam and Micro Issues

  • PW, WFI, Pure Steam micro specifications?
  • <1231> Starting water issues
  • <1231> Misunderstood issues clarified
  • <1231> Microbiological test issues clarified
  • <1231> Suggested micro test method
  • <1231> Micro Specifications
  • <1231> Alert and Action Levels and max's
  • Recent/Upcoming USP water changes
  • Discrepancies between pharmacopeia's

 

Speaker

Teri C. Soli

Principal Consultant, Soli Pharma Solutions

Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli's career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems.

He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, is the author of USP's Informational Chapter <1231> on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has motivated many audiences and course attendees with practical water system information. He has also authored many articles and chapters in books and industry standards published by PDA and ISPE including chapter authorships in the 2nd ed. ISPE Baseline Guide for Water and Steam Systems, ISPE's Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems, and chapters in several PDA books on pharmaceutical and laboratory water systems and biofilm control. He earned a Ph.D. degree in Microbiology and Immunology from the University of Arizona and M.S. and B.S. degrees in Microbiology from Texas A&M University.

 

Location:  Sydney, Australia Date:  September 11th & 12th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  Hilton Sydney 488 George Street, Sydney, Australia 2000

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,695.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,695.00 From August 11 to September 09, Regular Price: $1,895.00

Register for 5 attendees   Price: $5,085.00      $8,475.00 You Save: $3,390.00 (40%)*

 Register for 10 attendees   Price: $9,322.00      $16,950.00 You Save: $7,628.00 (45%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901122SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

115718| Multiple Locations| FDA's Software Monsters Cybersecurity, Interoperability, Mobile Apps 2017|

Course "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of dollars. Life supporting and life sustaining healthcare grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice.

The FDA looks at software in one of three ways: Standalone, such as for a mobile app; device-based software used to control a device's performance, or simply electronic records. FDA's risk classification will gradually clarify how it intends to manage the health risks with premarket and postmarket controls. What the FDA did not see was the cancer of cybersecurity attacks, the failure of interoperability, and the explosion in the use of wireless communication and mobile apps.

Inadequate cybersecurity programs and the lack of interoperability for healthcare users pose the greatest threat to any healthcare system. Software exploitations are using more sophisticated approaches and the hackers' programs are readily available on the "dark web."

The increasing sophistication required to protect software programs and have them work with other programs requires progressive software design and software validation considerations. In many instances, validation is limited to the immediate use of the software rather than its environment of use, its performance with other software programs and software hacking. FDA can ask you what you have considered before you take a product to market. Whether your software can survive unscathed is another question. When software causes a problem, fixing the malfunction or "bug" may be more difficult as software becomes more sophisticated, customized by users and placed in a network system. In these kinds of circumstances, it is difficult to decide who is responsible for managing and fixing the software problems, preventing them from recurring. This becomes a major regulatory headache for FDA and generates business-to-business conflicts. When firms are designing and marketing software, they should be mindful of the unknowns that lurk in the future of software regulated as a device by the FDA.

 

Why you should attend:

 

For decades, firms have experienced serious problems with software and have been at a loss to make a well-informed follow up. Software problems represent one of the most common root causes for recalls that are associated with deaths and serious injuries beyond what should be necessary to quantify. FDA sees firms revise software only to create more problems rather than solve them. The infusion pump industry is a classic example that drove FDA to implement a new rigorous paradigm for premarket review and performance criteria evaluation.

The growth of the medical software industry outpaces how FDA's regulatory process is designed. How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump? In some instances, clinicians have weighed the risk of software failure against the benefits of using a device at all. You need to understand and apply the current provisions that NIST has put forth in recent reports FDA will integrate them into its regulatory oversight of cybersecurity management.

Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. Can one software program defeat the performance capability or back up safety features of another software program? When interoperability problems surface, which software manufacturer takes the lead to solve the problem and deal with proprietary software issues?

These are the kinds of issues that will be highlighted during the webinar. The issues require careful consideration even though no obvious answer appears at hand.

 

Topics:

 

  • FDA's risk-based regulatory strategy
  • Cybersecurity
  • Interoperability
  • National Institute of Standards and Technology
  • Voluntary standards and programs
  • Mobile Apps
  • Premarket software validation and design requirements
  • Postmarket Software recalls

 

Who Will Benefit:

 

  • Regulatory Affairs
  • Quality Assurance
  • Software Design Engineers
  • Manufacturing
  • Complaint Dept.
  • Hospital Risk Dept.
  • Own label marketers

 

 

 

Agenda:

 

 

Day 1 Schedule

 

9:00 am - 10:15 am

Lecture 1: FDA authority and regulatory program

  • Types of Software are devices
  • Regulatory strategy
  • Risk classification
  • Office of the National Coordinator (ONC) for Health Information Protection
  • Software regulatory applications
  • FDA Guidance
    • Premarket submissions
    • Paradigms: aeronautics

10:15am - 10:30am Break

10:30 am - 12:00 am

  • Quality System Regulation (QSR)
    • Design verification and validation
    • Voluntary standards
    • Corrective and Prevent Action Plans
  • Voluntary standards
  • Recalls:
    • Service / maintenance / recall.
    • Implementation strategy
  • Corrections and Removals reporting
  • Updates: FDA vs. non-FDA
  • Predictive analytics

12:00 PM - 1:00 PM Lunch

1:00 PM - 2:30 PM

Lecture 2: Interoperability

  • Compatibility by design
    • Hardware
    • Software
  • Labeling
    • Precautions
    • Instructions for use
  • Use of Voluntary Standards

2:30 PM - 2:45 PM Break

2:45 PM - 4:15 PM

  • Proprietary information
  • Failure management / follow up
  • User's vs. manufacturer's legal responsibility
    • System configuration
    • Customization
    • Environment of use
    • Professional

Day 2 Schedule

9:00 am - 10:15 am

Lecture 1: Cybersecurity

  • Device vulnerabilities: malfunction and failure
  • Pre-emptive design and evolution
  • Hackers' malware/virus strategy

10:30 am - 10:45 am Break

10:45 am - 12:00 pm

  • Post-event management
    • Corrective and preventive action for software
    • Disclosure to users
    • Reports to the FDA waiver
  • National Institute of Standards and Technology Reports

12:00 PM - 1:00 PM Lunch

1:00 PM - 2:30 PM

Lecture 2: Medical Mobile Applications (mobile apps)

  • Mobile apps defined as a device
  • FDA regulatory strategy and guidance
  • National Institute of Science and Technology Report and Collaboration
  • Updates (FDA vs. non-FDA updates)
    • Criteria for corrective and preventive action deemed recalls
    • Reports of Corrections and Removals
    • Reports of adverse events

2:30 PM - 2:45 PM Break

2:45 PM - 4:30 PM

Lecture 3: Professional vs. lay use / home use

  • Labeling: instructions for use and precautions
  • Environment of use
  • FDA regulation of accessories
  • Federal Communications Commission (FCC) regulation

 

Speaker

Casper Uldriks

ex-FDA Expert and former Associate Center Director of CDRH

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specializes in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight, LLC, a consulting service for FDA matters.

 

Location:  SFO, CA Date:  September 7th & 8th, 2017 and Time: 9:00 AM to 4:30 PM

 

Venue:  Hilton San Francisco Airport Bayfront   600 Airport Blvd, Burlingame, CA 94010

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until July 20, Early Bird Price: $1,295.00 From July 21 to September 05, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901104SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

115719| Multiple Locations| FDA's Software Monsters Cybersecurity, Interoperability, Mobile Apps 2017|

Course "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of dollars. Life supporting and life sustaining healthcare grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice.

The FDA looks at software in one of three ways: Standalone, such as for a mobile app; device-based software used to control a device's performance, or simply electronic records. FDA's risk classification will gradually clarify how it intends to manage the health risks with premarket and postmarket controls. What the FDA did not see was the cancer of cybersecurity attacks, the failure of interoperability, and the explosion in the use of wireless communication and mobile apps.

Inadequate cybersecurity programs and the lack of interoperability for healthcare users pose the greatest threat to any healthcare system. Software exploitations are using more sophisticated approaches and the hackers' programs are readily available on the "dark web."

The increasing sophistication required to protect software programs and have them work with other programs requires progressive software design and software validation considerations. In many instances, validation is limited to the immediate use of the software rather than its environment of use, its performance with other software programs and software hacking. FDA can ask you what you have considered before you take a product to market. Whether your software can survive unscathed is another question. When software causes a problem, fixing the malfunction or "bug" may be more difficult as software becomes more sophisticated, customized by users and placed in a network system. In these kinds of circumstances, it is difficult to decide who is responsible for managing and fixing the software problems, preventing them from recurring. This becomes a major regulatory headache for FDA and generates business-to-business conflicts. When firms are designing and marketing software, they should be mindful of the unknowns that lurk in the future of software regulated as a device by the FDA.

 

Why you should attend:

 

For decades, firms have experienced serious problems with software and have been at a loss to make a well-informed follow up. Software problems represent one of the most common root causes for recalls that are associated with deaths and serious injuries beyond what should be necessary to quantify. FDA sees firms revise software only to create more problems rather than solve them. The infusion pump industry is a classic example that drove FDA to implement a new rigorous paradigm for premarket review and performance criteria evaluation.

The growth of the medical software industry outpaces how FDA's regulatory process is designed. How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump? In some instances, clinicians have weighed the risk of software failure against the benefits of using a device at all. You need to understand and apply the current provisions that NIST has put forth in recent reports FDA will integrate them into its regulatory oversight of cybersecurity management.

Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. Can one software program defeat the performance capability or back up safety features of another software program? When interoperability problems surface, which software manufacturer takes the lead to solve the problem and deal with proprietary software issues?

These are the kinds of issues that will be highlighted during the webinar. The issues require careful consideration even though no obvious answer appears at hand.

 

Topics:

 

  • FDA's risk-based regulatory strategy
  • Cybersecurity
  • Interoperability
  • National Institute of Standards and Technology
  • Voluntary standards and programs
  • Mobile Apps
  • Premarket software validation and design requirements
  • Postmarket Software recalls

 

Who Will Benefit:

 

  • Regulatory Affairs
  • Quality Assurance
  • Software Design Engineers
  • Manufacturing
  • Complaint Dept.
  • Hospital Risk Dept.
  • Own label marketers

 

 

 

Agenda:

 

 

Day 1 Schedule

 

9:00 am - 10:15 am

Lecture 1: FDA authority and regulatory program

  • Types of Software are devices
  • Regulatory strategy
  • Risk classification
  • Office of the National Coordinator (ONC) for Health Information Protection
  • Software regulatory applications
  • FDA Guidance
    • Premarket submissions
    • Paradigms: aeronautics

10:15am - 10:30am Break

10:30 am - 12:00 am

  • Quality System Regulation (QSR)
    • Design verification and validation
    • Voluntary standards
    • Corrective and Prevent Action Plans
  • Voluntary standards
  • Recalls:
    • Service / maintenance / recall.
    • Implementation strategy
  • Corrections and Removals reporting
  • Updates: FDA vs. non-FDA
  • Predictive analytics

12:00 PM - 1:00 PM Lunch

1:00 PM - 2:30 PM

Lecture 2: Interoperability

  • Compatibility by design
    • Hardware
    • Software
  • Labeling
    • Precautions
    • Instructions for use
  • Use of Voluntary Standards

2:30 PM - 2:45 PM Break

2:45 PM - 4:15 PM

  • Proprietary information
  • Failure management / follow up
  • User's vs. manufacturer's legal responsibility
    • System configuration
    • Customization
    • Environment of use
    • Professional

Day 2 Schedule

9:00 am - 10:15 am

Lecture 1: Cybersecurity

  • Device vulnerabilities: malfunction and failure
  • Pre-emptive design and evolution
  • Hackers' malware/virus strategy

10:30 am - 10:45 am Break

10:45 am - 12:00 pm

  • Post-event management
    • Corrective and preventive action for software
    • Disclosure to users
    • Reports to the FDA waiver
  • National Institute of Standards and Technology Reports

12:00 PM - 1:00 PM Lunch

1:00 PM - 2:30 PM

Lecture 2: Medical Mobile Applications (mobile apps)

  • Mobile apps defined as a device
  • FDA regulatory strategy and guidance
  • National Institute of Science and Technology Report and Collaboration
  • Updates (FDA vs. non-FDA updates)
    • Criteria for corrective and preventive action deemed recalls
    • Reports of Corrections and Removals
    • Reports of adverse events

2:30 PM - 2:45 PM Break

2:45 PM - 4:30 PM

Lecture 3: Professional vs. lay use / home use

  • Labeling: instructions for use and precautions
  • Environment of use
  • FDA regulation of accessories
  • Federal Communications Commission (FCC) regulation

 

Speaker

Casper Uldriks

ex-FDA Expert and former Associate Center Director of CDRH

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specializes in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight, LLC, a consulting service for FDA matters.

 

Location:  SFO, CA Date:  September 7th & 8th, 2017 and Time: 9:00 AM to 4:30 PM

 

Venue:  Hilton San Francisco Airport Bayfront   600 Airport Blvd, Burlingame, CA 94010

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until July 20, Early Bird Price: $1,295.00 From July 21 to September 05, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901104SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

115716| Multiple Locations| Safety Management and OSHA Compliance 2017|

 

Overview:

 

Development of a safety program to save costs, delayed schedules and the human cost of injury or death.

Safety management guidelines and techniques for the engineering, construction, and scientific professions.

Includes costs of preparing the necessary safety documentation.

It will emphasize using multiple techniques for each safety task.

It will discuss costs of professional services from consultants.

There will be brief exercise each day.

The course will discuss the costs of accidents in an occupational environment.

It will discuss the costs of operating industrial and construction projects safely in accordance 29 CFR 1910 and 29 CFR 1926.

Discussion of how Environmental releases and safety violations can impact your profitability.

How accidents affect production schedules and result in civil or in some cases criminal action. Multiple safety violations can cost your company hundreds of thousands of dollars.

Upper management's commitment to an environmental and safety compliance program is essential This seminar will instruct you on how to develop a safety inspection protocol that will help reduce the risks of environmental incidents and accidents.

 

Why you should attend:

 

An OSHA violation can result in significant fines and suspended operations

A Safety Management Program is a necessary and cost effective endeavor.

Lack of a safety program leads to additional costs, delayed schedule and the human cost of injury or death.

This course will present safety management guidelines and techniques for the engineering, construction, and scientific professions. This will include costs of preparing the necessary documentation. It will emphasize using multiple techniques for each safety program. It will discuss costs of professional services from consultants. There will be at least one brief exercise that students will conduct on their own with guidance from the Instructor. The course will discuss the costs of accidents in an occupational environment. It will discuss the costs of operating industrial and construction projects safely in accordance 29 CFR 1910 and 29 CFR 1926.

Environmental releases and safety violations can impact your profitability, affect production schedules and result in civil or in some cases criminal action. Multiple safety violations can cost your company hundreds of thousands of dollars. A commitment to reducing this liability starts with upper management's commitment to an environmental and safety compliance program. A foundation of an effective safety management and environmental compliance program is an effective inspection and auditing program. This seminar will instruct you on how to develop a safety inspection protocol that will help reduce the risks of environmental incidents and accidents.

 

Areas Covered in the Session:

 

  • Chemical safety
  • Developing a safety management program
  • Safety aspects of environmental compliance
  • Confined space safety
  • Introduction to OSHA
  • Office safety
  • Hazardous communications
  • Safety Data Sheets
  • DOT hazardous material classes and divisions

 

Who Will Benefit:

 

  • Owners
  • Managers
  • Safety Managers
  • Environmental Compliance Managers
  • Engineers
  • Architects
  • Landscape Architects

 

 

Agenda:

 

 

Day 1 Schedule 

Lecture 1:

Introduction to OSHA

Lecture 2:

Personal protective equipment

Lecture 3:

OSHA health and safety programs 
Fall protection

Lecture 4:

How to conduct inspections and audits

Day 2 Schedule

Lecture 1:

Senior management's role in a safety management program

Lecture 2:

Confined space safety

Lecture 3:

Construction safety

Lecture 4:

Development of a safety management program

 

 

Speaker

Keith Warwick

President, Patty & Keith Inc. 

Keith Warwick is a licensed professional engineer in California and has been licensed in Tennessee, Indiana, Illinois and New York when he worked in those locales. He is owner and President of PATTY & KEITH INC. Keith is a graduate of the University of California at Davis with a degree in Civil Engineering. He has 35 years of environmental compliance, safety management, and civil engineering experience. He is the author of California's Highway 99: Modesto to Bakersfield.

 

Location:  Washington, DC Date:  September 7th & 8th, 2017 and Time: 9:00 AM to 3:30 PM

 

Venue:  WILL BE ANNOUNCED SOON , Washington, DC

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until July 31, Early Bird Price: $1,295.00 From August 01 to September 05, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees   Price: $7,122.00     $12,950.00 You Save: $5,828.00 (45%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901090SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

115717| Multiple Locations| Safety Management and OSHA Compliance 2017|

 

Overview:

 

Development of a safety program to save costs, delayed schedules and the human cost of injury or death.

Safety management guidelines and techniques for the engineering, construction, and scientific professions.

Includes costs of preparing the necessary safety documentation.

It will emphasize using multiple techniques for each safety task.

It will discuss costs of professional services from consultants.

There will be brief exercise each day.

The course will discuss the costs of accidents in an occupational environment.

It will discuss the costs of operating industrial and construction projects safely in accordance 29 CFR 1910 and 29 CFR 1926.

Discussion of how Environmental releases and safety violations can impact your profitability.

How accidents affect production schedules and result in civil or in some cases criminal action. Multiple safety violations can cost your company hundreds of thousands of dollars.

Upper management's commitment to an environmental and safety compliance program is essential This seminar will instruct you on how to develop a safety inspection protocol that will help reduce the risks of environmental incidents and accidents.

 

Why you should attend:

 

An OSHA violation can result in significant fines and suspended operations

A Safety Management Program is a necessary and cost effective endeavor.

Lack of a safety program leads to additional costs, delayed schedule and the human cost of injury or death.

This course will present safety management guidelines and techniques for the engineering, construction, and scientific professions. This will include costs of preparing the necessary documentation. It will emphasize using multiple techniques for each safety program. It will discuss costs of professional services from consultants. There will be at least one brief exercise that students will conduct on their own with guidance from the Instructor. The course will discuss the costs of accidents in an occupational environment. It will discuss the costs of operating industrial and construction projects safely in accordance 29 CFR 1910 and 29 CFR 1926.

Environmental releases and safety violations can impact your profitability, affect production schedules and result in civil or in some cases criminal action. Multiple safety violations can cost your company hundreds of thousands of dollars. A commitment to reducing this liability starts with upper management's commitment to an environmental and safety compliance program. A foundation of an effective safety management and environmental compliance program is an effective inspection and auditing program. This seminar will instruct you on how to develop a safety inspection protocol that will help reduce the risks of environmental incidents and accidents.

 

Areas Covered in the Session:

 

  • Chemical safety
  • Developing a safety management program
  • Safety aspects of environmental compliance
  • Confined space safety
  • Introduction to OSHA
  • Office safety
  • Hazardous communications
  • Safety Data Sheets
  • DOT hazardous material classes and divisions

 

Who Will Benefit:

 

  • Owners
  • Managers
  • Safety Managers
  • Environmental Compliance Managers
  • Engineers
  • Architects
  • Landscape Architects

 

 

Agenda:

 

 

Day 1 Schedule 

Lecture 1:

Introduction to OSHA

Lecture 2:

Personal protective equipment

Lecture 3:

OSHA health and safety programs 
Fall protection

Lecture 4:

How to conduct inspections and audits

Day 2 Schedule

Lecture 1:

Senior management's role in a safety management program

Lecture 2:

Confined space safety

Lecture 3:

Construction safety

Lecture 4:

Development of a safety management program

 

 

Speaker

Keith Warwick

President, Patty & Keith Inc. 

Keith Warwick is a licensed professional engineer in California and has been licensed in Tennessee, Indiana, Illinois and New York when he worked in those locales. He is owner and President of PATTY & KEITH INC. Keith is a graduate of the University of California at Davis with a degree in Civil Engineering. He has 35 years of environmental compliance, safety management, and civil engineering experience. He is the author of California's Highway 99: Modesto to Bakersfield.

 

Location:  Washington, DC Date:  September 7th & 8th, 2017 and Time: 9:00 AM to 3:30 PM

 

Venue:  WILL BE ANNOUNCED SOON , Washington, DC

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until July 31, Early Bird Price: $1,295.00 From August 01 to September 05, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees   Price: $7,122.00     $12,950.00 You Save: $5,828.00 (45%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901090SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

115714| Multiple Locations| Why you Should be Worried about HIPAA 2017|

Overview:

 

This seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits or (even worse) litigation occurs against your organization under state laws of negligence.

It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.

The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers

I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.

I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you).

In addition, this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures.

Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required.

 

Why you should attend:

 

There are major changes to HIPAA set forth by the Federal government whereby patients can receive remedies for HIPAA violations and business associates (i.e. law firms) must now comply directly with HIPAA.

Omnibus has changed the HIPAA landscape for good!

State laws are now in place increasing liability for patient remedies!

THESE DAYS THE TRIAL ATTORNEYS ARE MORE DANGEROUS THAN THE FEDERAL GOVERNMENT!!

This once rarely enforced law has changed and you need to know what's going on!

Protect your practice or business!

Why are the Feds enforcing after all these years?

We will be discussing some of the changes taking place in Washington with the Health and Human Services in regards to the enforcement of the HIPAA laws already on the books.

I will also thoroughly go through multiple litigated cases I have been a part of involving patients suing for HIPAA violations - THIS IS A MUST TO UNDERSTAND!!

Changes affecting law firms dealing with protected health information

I will also be discussing factors might cause an unwanted visit or letter from the Office of Civil Rights and how to prepare for the audit and deal with the Feds.

 

Areas Covered in the Session:

 

  • History of HIPAA
  • HITECH
  • HIPAA Omnibus Rule
  • How to perform a HIPAA Security Risk Assessment
  • What is involved in a Federal audit and how is it conducted
  • Risk factors for a federal audit
  • EHR and HIPAA
  • Business Continuity/Disaster Recovery Planning
  • Business Associates and HIPAA
  • In depth discussions on IT down to the nuts and bolts
  • BYOD
  • Risk factors that can cause an audit (low hanging fruit)
  • New rules which grant states ability to sue citing HIPAA on behalf of a patient
  • New funding measures
  • ...much, much more.

 

Who Will Benefit:

 

  • Practice Managers
  • Compliance Officers, and any Business Associates Privy to Private Health Information and Under the Auspices of this Law.

 

 

 

Agenda:

 

 

Day 1 Schedule

Lecture 1: HIPAA -History

Lecture 2: HIPAA Privacy Rule vs HIPAA Security Rule

Lecture 3: HITECH Act

Lecture 4: Information Technology

Lecture 5: Breach Notification Rule

Lecture 6: Omnibus Rule

Lecture 7:Business Associates

Lecture 8: Current Court Cases (precedence)

Lecture 9: Paper Based PHI Concerns

Lecture 10: Disaster Recovery Concerns (Paper)

Lecture 11: Psych and Infectious Disease

 Day 2 Schedule 

Lecture 1: Choosing a HIPAA Consultant

Lecture 2: Choosing an IT Group

Lecture 3: Disaster Recovery Concerns (Electronic)

Lecture 4: Physical Setup

Lecture 5: Overseas Outsourcing

Lecture 6: BYOD

Lecture 7: Texting and Emailing

Lecture 8: What the Feds are Looking For (low hanging fruit)

Lecture 9: What are Factors That Can Get Your Practice Audited

Lecture 10: State Laws and Patient Ability to Sue

Lecture 11: How to Conduct a Risk Assessment

Lecture 12: How to Write Policies and Procedures

 

 

Speaker

Brian L Tuttle

Sr Compliance Consultant & IT Manager, InGauge Healthcare Solutions 

Brian L Tuttle, CPHIT, CHP, CHA, CBRA, CISSP, CCNA

Brian Tuttle is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified HIPAA Administrator (CHA), Certified Business Resilience Auditor (CBRA), Certified Information Systems Security Professional (CISSP) with over 17 years' experience in Health IT and Compliance Consulting.

With vast experience in health IT systems (i.e. practice management, EHR systems, imaging, transcription, medical messaging, etc.) as well as over 17 years' experience in standard Health IT with multiple certifications and hands-on knowledge, Brian serves as compliance consultant and has conducted onsite and remote risk assessments for over 1000 medical practices, hospitals, health departments, insurance plans, and business associates throughout the United States.

In addition, Mr Tuttle has served in multiple litigated court cases serving as an expert witness offering input related to best practices and requirements for securing and providing patient access to protected health information. Mr. Tuttle has also worked directly with the Office of Civil Rights (OCR) both in defending covered entities and business associates as well as being asked by the Federal government to audit covered entities and business associates on behalf of the OCR.

Almost all of Brian's clients are earned by referral with little or no advertising.

Brian is well known and highly regarded in medical circles throughout the United States for his quality work and down home southern charm.

Mr. Tuttle has a Master's Degree in Health Sciences from Georgia State University.

 

Location:  SFO, CA Date:  September 7th & 8th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  Hilton San Francisco Airport Bayfront   600 Airport Blvd, Burlingame, CA 94010

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until July 31, Early Bird Price: $1,295.00 From August 01 to September 05, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901046SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

115715| Multiple Locations| Why you Should be Worried about HIPAA 2017|

Overview:

 

This seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits or (even worse) litigation occurs against your organization under state laws of negligence.

It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.

The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers

I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.

I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you).

In addition, this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures.

Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required.

 

Why you should attend:

 

There are major changes to HIPAA set forth by the Federal government whereby patients can receive remedies for HIPAA violations and business associates (i.e. law firms) must now comply directly with HIPAA.

Omnibus has changed the HIPAA landscape for good!

State laws are now in place increasing liability for patient remedies!

THESE DAYS THE TRIAL ATTORNEYS ARE MORE DANGEROUS THAN THE FEDERAL GOVERNMENT!!

This once rarely enforced law has changed and you need to know what's going on!

Protect your practice or business!

Why are the Feds enforcing after all these years?

We will be discussing some of the changes taking place in Washington with the Health and Human Services in regards to the enforcement of the HIPAA laws already on the books.

I will also thoroughly go through multiple litigated cases I have been a part of involving patients suing for HIPAA violations - THIS IS A MUST TO UNDERSTAND!!

Changes affecting law firms dealing with protected health information

I will also be discussing factors might cause an unwanted visit or letter from the Office of Civil Rights and how to prepare for the audit and deal with the Feds.

 

Areas Covered in the Session:

 

  • History of HIPAA
  • HITECH
  • HIPAA Omnibus Rule
  • How to perform a HIPAA Security Risk Assessment
  • What is involved in a Federal audit and how is it conducted
  • Risk factors for a federal audit
  • EHR and HIPAA
  • Business Continuity/Disaster Recovery Planning
  • Business Associates and HIPAA
  • In depth discussions on IT down to the nuts and bolts
  • BYOD
  • Risk factors that can cause an audit (low hanging fruit)
  • New rules which grant states ability to sue citing HIPAA on behalf of a patient
  • New funding measures
  • ...much, much more.

 

Who Will Benefit:

 

  • Practice Managers
  • Compliance Officers, and any Business Associates Privy to Private Health Information and Under the Auspices of this Law.

 

 

 

Agenda:

 

 

Day 1 Schedule

Lecture 1: HIPAA -History

Lecture 2: HIPAA Privacy Rule vs HIPAA Security Rule

Lecture 3: HITECH Act

Lecture 4: Information Technology

Lecture 5: Breach Notification Rule

Lecture 6: Omnibus Rule

Lecture 7:Business Associates

Lecture 8: Current Court Cases (precedence)

Lecture 9: Paper Based PHI Concerns

Lecture 10: Disaster Recovery Concerns (Paper)

Lecture 11: Psych and Infectious Disease

 Day 2 Schedule 

Lecture 1: Choosing a HIPAA Consultant

Lecture 2: Choosing an IT Group

Lecture 3: Disaster Recovery Concerns (Electronic)

Lecture 4: Physical Setup

Lecture 5: Overseas Outsourcing

Lecture 6: BYOD

Lecture 7: Texting and Emailing

Lecture 8: What the Feds are Looking For (low hanging fruit)

Lecture 9: What are Factors That Can Get Your Practice Audited

Lecture 10: State Laws and Patient Ability to Sue

Lecture 11: How to Conduct a Risk Assessment

Lecture 12: How to Write Policies and Procedures

 

 

Speaker

Brian L Tuttle

Sr Compliance Consultant & IT Manager, InGauge Healthcare Solutions 

Brian L Tuttle, CPHIT, CHP, CHA, CBRA, CISSP, CCNA

Brian Tuttle is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified HIPAA Administrator (CHA), Certified Business Resilience Auditor (CBRA), Certified Information Systems Security Professional (CISSP) with over 17 years' experience in Health IT and Compliance Consulting.

With vast experience in health IT systems (i.e. practice management, EHR systems, imaging, transcription, medical messaging, etc.) as well as over 17 years' experience in standard Health IT with multiple certifications and hands-on knowledge, Brian serves as compliance consultant and has conducted onsite and remote risk assessments for over 1000 medical practices, hospitals, health departments, insurance plans, and business associates throughout the United States.

In addition, Mr Tuttle has served in multiple litigated court cases serving as an expert witness offering input related to best practices and requirements for securing and providing patient access to protected health information. Mr. Tuttle has also worked directly with the Office of Civil Rights (OCR) both in defending covered entities and business associates as well as being asked by the Federal government to audit covered entities and business associates on behalf of the OCR.

Almost all of Brian's clients are earned by referral with little or no advertising.

Brian is well known and highly regarded in medical circles throughout the United States for his quality work and down home southern charm.

Mr. Tuttle has a Master's Degree in Health Sciences from Georgia State University.

 

Location:  SFO, CA Date:  September 7th & 8th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  Hilton San Francisco Airport Bayfront   600 Airport Blvd, Burlingame, CA 94010

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until July 31, Early Bird Price: $1,295.00 From August 01 to September 05, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

[email protected]  

[email protected] 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901046SEMINAR?findcpd-September-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

115711| Multiple Locations| IQ IAM Level 5 Diploma in Management and Leadership|

The London College of Art and Media offers flexible study options and highly competitive prices for university level courses without the university price. Our courses are fully accredited and recognised by employers.

The IQ IAM Level 5 NVQ Diploma in Management and Leadership (QCF) is a qualification aimed at individuals who intend to develop and gain formal recognition of their competence of working as managers, heads of departments or directors. The qualification is generic, so it is suitable for individuals working or with access to work in a variety of management and leadership roles.  In the mandatory units, all learners will cover the essentials of contributing to the development of strategic plans, designing business processes, managing strategic change and providing leadership and management. There are a range of optional units allowing learners scope to choose those areas most relevant to them.  You can use evidence from your place of work, or from voluntary work, so you can learn while you earn. 

Please note that registration for this qualification will end on 31st August 2017. 

Please see our website for our current discounts.

For a limited time this course may be started for £25.00 plus registration fees for self-financing students and the remainder can be paid in monthly instalments. Find us online via myartscollege.com

 

 

 

115707| Multiple Locations| TUV Functional Safety Training Course IEC 61511|

As part of the TUV SUD Functional Safety Certification Program, =Method offer the Functional Safety for Safety Instrumented Systems Professionals training course. The course is universally recognised as the essential qualification for professionals and engineers working with any aspect of the Functional Safety lifecycle in the Process and Power industries. The course provides an overview of the entire IEC 61511 lifecycle and details how key aspects such as Verification, Validation, Functional Safety Assessments and Audits can be practically implemented. On successful completion of the course and the examination, candidates that can demonstrate adequate level of experience will achieve the “TUV Functional Safety Professional” award. Certification takes place in cooperation with TUV SUD.

115708| Multiple Locations| TUV Functional Safety Training Course IEC 61511|

As part of the TUV SUD Functional Safety Certification Program, =Method offer the Functional Safety for Safety Instrumented Systems Professionals training course. The course is universally recognised as the essential qualification for professionals and engineers working with any aspect of the Functional Safety lifecycle in the Process and Power industries. The course provides an overview of the entire IEC 61511 lifecycle and details how key aspects such as Verification, Validation, Functional Safety Assessments and Audits can be practically implemented. On successful completion of the course and the examination, candidates that can demonstrate adequate level of experience will achieve the “TUV Functional Safety Professional” award. Certification takes place in cooperation with TUV SUD.

115704| CPD Gateway| Sports Injuries of The Knee and Foot & Ankle|

Early Bird Booking Offer - All courses in 2017 will launch with a discounted price for a limited time - Book this course now at a reduced cost of £30 + VAT - Finishing 13.09.17

'Sports Injuries Of The Foot and Ankle’ by Mr Laurence James

Mr James will begin by discussing the 5 most common injuries of the foot and ankle, including Ankle Sprains, Achilles Tendon Injuries, Osteochondral Injuries, Stress Fractures and Turf toe. In each of these areas, he will then explore what common signs to look for and the tests used to diagnose them. Operative and non-operative treatments will then be discussed as well looking at imaging. 

‘Sports Injuries of the Knee’ by Mr Jonathan Bird

During this talk Mr Bird will answer the key questions of how and why they get injured – and how to examine them. He will start by covering the anatomy and bio-mechanics of the knee to fully understand how the knee moves and why, then will move on to discuss his 'top tips' for examinations and what tests to use. Mr Bird will then debunk the latest myths surrounding surgery and new developments. 
 Agenda? Anatomy, 
? Biomechanics, 
? Examination, 
? Clinical assessments, 
? Investigations, 
? Treatment options and when to operate, and 
? The latest techniques - debunking the myths and latest “black magic” treatments

Cost: £30 + VAT

Admission to course, 2.5 hours CPD, speaker's handout, tea and coffee on arrival, refreshements break during the interval, Certificate of Attendance.

Who should attend? Chiropractors; Osteopaths; Physiotherapists; Podiatrists; Sports Therapists; Hand Therapists; Occupational Therapists

115703| CPD Gateway| The Usual Suspects v Unusual Diagnoses In The Shoulder|

Early Bird Booking Offer - All courses in 2017 will launch with a discounted price for a limited time - Book this course now at a reduced cost of £35 + VAT.

Mr Adrian Carlos and Mr Livio Di Mascio will go through real cases and discuss their presentation, clinical findings, investigations and treatment of the most common and also some unusual shoulder conditions that you will see in your clinics.
 
There will be plenty of opportunity to ask questions and for debate in this very interactive session. All areas of shoulder pathology and the most up to date treatments will be discussed, which will allow you to ask those questions you have been dying to ask!
 
Clinical evaluation and shoulder examination will be covered and importantly when it is ideal to refer to your friendly upper limb service.
 
By the end of this two part session you will all be shoulder experts.

Mr Adrian Carlos and Mr Livio Di Mascio are both part of the upper limb team at London Sports Orthopaedics. They also are substantive consultants at Barts and the Royal London, one of the largest tertiary referral centres for elective and trauma orthopaedic services in London. 

 AgendaAreas covered: 

• Shoulder examination and clinical evaluation 
• Impingement and tendonitis 
• Rotator cuff tears 
• Frozen shoulder 
• Labral tears and instability 
• Superior labral lesions and LHB pathology 
• Treatment of common traumatic injuries 
• Neural entrapment 
• Shoulder arthritis and modern arthroplasty

£35+VAT

What's included? Admission to course, 2.5  hours CPD, speaker's handout of slides, teas and coffees on arrival, light refreshments break, Certificate of Attendance.

115702| CPD Gateway| An Update, Diagnosis and Treatment -Low Back Pain & SI Joint Disorders -Cheshunt|

Early Bird Booking Offer - All courses in 2017 will launch with a discounted price for a limited time - Book this course now at a reduced cost of £30 + VAT.

Low Back Pain - Is Surgery Ever A Good Idea?

Treating low back pain with surgery has always been controversial. A multinational multi-centre award winning study suggests there are conditions when surgery can be superior to non-operative management. Certainly our European and American cousins do far more back pain surgery than us! Why? Are they right? What are the controversies and what evidence is there to help guide appropriate treatment?

Newer treatments for back pain include disc supplementation, hydration and stem cell therapy. Is there any evidence for these techniques? What's involved and what are the potential risks and benefits?

During this talk, Mr Bob Chatterjee will discuss the story behind of the surgical treatment of back pain. Mr Chatterjee will explain the different viewpoints not only within the UK but also from his experience abroad. He will explain the latest scanning techniques to help identify patients whom may benefit from surgery, but perhaps most importantly describe a patient's journey through such surgery and how they recover afterwards. Having performed stem cell research at The Royal National Orthopaedic Hospital and currently performing trials in disc supplementation, Mr Chatterjee will update you on the latest progress and evidence for these newer treatments.

Sacroiliac Joint Disorders - Fact or Fiction?

In the first part of the 20th century, sacroiliac (SI) joint syndrome was the most common diagnosis for lumbago (low back pain). Any pain in the low back, buttock, or adjacent leg was usually referred to as SI joint syndrome. Before 1932, SI joint syndrome was a particularly popular diagnosis. There was actually a period referred to as the "Era of the SI Joint." However the diagnosis, then fell out of fashion as newer conditions took the limelight.

In the early 2000's, many doctors "rediscovered" the SI joint as a possible source of back pain. Yet even today, SI joint pain is often overlooked. Many doctors have not been trained to consider it. Many are still reluctant to believe a joint that has so little movement can cause back pain. Currently treatment of the condition surgically is popular on the continent, but is it a genuine entity? I travelled to Germany to train with sacroiliac joint treatment practitioners in order to understand the condition better.

I will describe the science behind the condition, who is at risk of getting sacroiliac problems. I will also explain how to diagnose the condition and what treatment options may be available.

Cost: £30 + VAT

Admission to course, 2 hours CPD, speaker's handout, tea and coffee on arrival, refreshements break during the interval, Certificate of Attendance.

Who should attend? Chiropractors; Osteopaths; Physiotherapists; Podiatrists; Sports Therapists; Hand Therapists; Occupational Therapists

115701| CPD Gateway| Problem Knees: An Artisan’s Science and Surgical Practice|

Early Bird Booking Offer - All courses in 2017 will launch with a discounted price for a limited time – Book this course now at a reduced cost of £30 + VAT.

CPD Gateway is pleased to present our first event in Cambridge! Hosted by The Sports Injury Clinic and Mr Jai Chitnavis.

This seminar will cover the anatomy and biomechanics of the knee. We will then explore the make up of the knee and relate these aspects to common disorders of the knee joint and contemporary surgical practice.  The evening will then move on to cover topics such as meniscal tears, articular cartilage wear and osteoarthritis, ligament tears and reconstructive surgery of the knee and anterior knee pain.   
 AgendaCommon disorders of the knee. 
The science and surgical practice of knee surgery

£30+VAT

What's included? Admission to course, 2 hours CPD, speaker's handout of slides, electronic copy of handout to be emailed to you prior to event, teas and coffees on arrival, teas/coffee and chef's treats during interval, Certificate of Attendance.

115700| CPD Gateway| 4th Annual Orthopaedic Examinations of the Spine, Upper and Lower Limb|

Early Bird Booking Offer - All courses in 2017 will launch with a discounted price for a limited time - Book this course now at a reduced cost of £120 + VAT

We are pleased to announce the return of one of our most poplar events, 'Orthopaedic Examinations of the Spine, Upper and Lower Limb', taking place in Central London on Saturday16th September 2017. As with previous years, this event will open with two talks followed by a rotation of 6 interactive examination stations.  In these examination stations you will working within small groups while a designated speaker demonstrates some of the latest examination techniques. This event provides a more personal CPD experience, allowing for more interactive discussion and learning. See below for talk overviews and details of each station:

Mr Ian McDermott : “MRI vs Clinical Judgement: is one better than the other?”

MRI will give you the answer — won’t it? MRI is a vitally important tool, but is it the be all and end all? 
 
This talk will highlight the strengths and weaknesses of MRI as it relates to the knee, addressing questions such as:
 
- When should you refer a knee patient for an MRI?
- Does it matter what scanner you use?
- How often is MRI right and how often is it just wrong?
- Is the diagnosis of ‘soft tissue injury’ in A&E based on just an X-ray ever really appropriate?
- Is it ever sensible to operate on someone’s knee without an MRI?
 
Mr Alexander Montgomery : "Radiology of the spine: when to refer and what not to miss

This talk covers aspects of radiology of the spine including MRI and spect, as well as the value of standard X-rays. It focuses on pitfalls and highlights instances where earlier referrals might be warranted and what conditions to be particularly aware of. 

Stations:

Hip - Mr Paul Jairaj & Dr Kal Parmar

This station will cover examination techniques and clinical reasoning to help differentiate common causes of hip and groin pain. By the end of the session participants should feel more confident examining this notoriously difficult area and have a better understanding of differential diagnosis including femoroacetabular impingement, osteoarthritis, sportsman’s hernia and pubic symphyseal/adductor issues.
 
Knee - Mr Ian McDermott / Mr Kash Akhtar / Mr Peter Hill 

This station will cover the examination of the knee, including how to examine the acutely injured knee, what key ‘red flag’ features to look out for, how to assess the patellofemoral compartment and how to check the PCL and posterolateral corner.
 
Foot & Ankle - Mr Ali Abbasian / Mr Henry Atkinson 


This station will over clinical examination for 1) Achilles Rupture / tendinopathy; 2) Ankle instability and impingement syndromes; 3) Flat foot and tibialis posterior problems; and 4) Forefoot issues - bunion / neuroma / hallux rigidus.
 
Shoulder - Mr Livio Di Mascio / Mr Adrian Carlos 


This station will cover examination techniques used to diagnose a comprehensive list of shoulder problems including the AC joint pathology (arthritis and dislocations), Impingement, Rotator cuff tears and Labral tears and instability. Post dislocation assessment and management,Capsulitis (frozen shoulder) and management, Clinical assessment of common presenting elbow pathologies will also be discussed.

Hand & Wrist - Mr Mark Phillips / Mr Ramon Tahmassebi

This station will provide a refresher for some of those finer points of examination of the upper limb from the elbow to the hand and wrist. We will cover nerve entrapment syndromes, ligamentous instability, tendon rupture and tendon mal-tracking. Specifically we will go through the Quadrega effect, Kirk Watson's test, intrinsic tightness, Elson's test, differentiation of FDS and FDP function and how to check for thumb base instability. This will be an interactive session and we will run through all of the palpable structures and examine the static and dynamic topographical anatomy.
 
Spine - Mr Alexander Montgomery / Mr Hanny Anwar


This station will cover examination techniques and clinical reasoning to help differentiate common causes of back pain and associated limb pathology. It will focus on the important features of spinal pathology that are commonly missed and detecting sinister pathology. Utilising both medical and surgical management guided by examination findings to manage the more complex patient.

Admission to course, 7.5 hours CPD, speaker's handout, tea and coffee on arrival, morning and afternoon break snacks, buffet lunch, Certificate of Attendance.

Who should attend? Chiropractors; Osteopaths; Physiotherapists; Podiatrists; Sports Therapists; Hand Therapists; Occupational Therapists

115699| CPD Gateway| Orthopaedic Masterclass: Back & Bones - Treating Patients with MSK Conditions|

Early Bird Booking Offer - All courses in 2017 will launch with a discounted price for a limited time - Book this course now at a reduced cost of £85 + VAT - FINISHING 19.07.17

We are pleased to announce our first all-day orthopaedic event in Northampton. Join us on Saturday 19th August 2017, 9.30am – 4.30pm for an event delivered by leading consultants from The BMI Three Shires Hospital. Topics covered will range from hip osteoarthritis to treating frozen shoulder, and alleviate knee and hand issues to post-operative spinal treatment – this event has something for everyone! 

Session 1: Mr Gregor Kerr, Shoulder and Upper Limb Surgeon – Hand & Wrist, will cover the following topics:

  • Hand therapists, the role in supporting hand surgeons
  • Examining the hand
  • When hand surgery is required
  • Strengthening exercises for wrists

 
Session 2: Mr Pierre Nasr, Hip & Knee Surgeon – Hip, will cover the following topics:

  • Hip Osteoarthritis, Red flags to look out for when examining patients,
  • None hip causes of hip pain
  • Practical Examination of the hip

 
Session 3: Mr Divyang Shukla, Shoulder and Upper Limb Surgeon  - Shoulder, will cover the following topics:

  • Identifying and treating frozen shoulder in primary care
  • Examination techniques for rotator cuff
  • When to refer

 
Session 4: Mr Simon West, Hip & Knee Surgeon – Knees, will cover the following topics:

  • Aspiration of Knees
  • Exercises to alleviate knee issues
  • Post-operative care of arthroscopic knee surgery

 
Session 5: Mr Ramanathan Natarajan, Foot & Ankle Surgeon – Foot & Ankle, will cover the following topics:

  • Plantar fasciitis, how to examine, diagnose and what treatments would be suitable
  • Orthotics and medical treatment of foot and ankle problems

 
Session 6: Professor Amjad Shad, Neurosurgeon – Back, will cover the following topics:

  • The examination of the spine, and none spinal causes of back pain
  • Post-operative spinal treatment from physiotherapist and osteopaths.

Speaker: BMI Three Shires Surgeons

£85 + VAT Early Bird!

Admission to course, 7 hours CPD, speaker's handout, tea and coffee on arrival, morning and afternoon break snacks, buffet lunch, Certificate of Attendance.

Who should attend? Chiropractors; Osteopaths; Physiotherapists; Podiatrists; Sports Therapists; Hand Therapists; Occupational Therapists

115698| CPD Gateway| Ultrasound Scanning of Common Musculoskeletal Conditions - Regents Park|

Early Bird Booking Offer - All courses in 2017 will launch with a discounted price for a limited time - Book this course now at a reduced cost of £35 + VAT.

Back by popular demand, please welcome our next Ultrasound event! Many Sports and MSK Physicians have skills in musculoskeletal ultrasound in the outpatient setting. This has become a vital adjunct and aids in the diagnosis of common musculoskeletal complaints.
 
The sessions will focus on indications for ultrasound with live scanning of volunteers from the audience. Any structures of interest will be explained and approach to injections with important landmarks identified. Any pathology identified will be detailed and explained in this highly interactive CPD event. 
 
The first part of the event will cover upper limb and the second part lower limb detailing structures of the: shoulder, elbow, wrist, hip, knee, foot and ankle.


 Agenda

Session 1: 

- Introduction to upper limb ultrasound - overview, indications 
- Live scanning of volunteers - shoulder, elbow and wrist 

Session 2: 

- Introduction to lower limb ultrasound - overview and indications 
- Live scanning of volunteers - hip, knee, foot and ankle

Cost: £35 + VAT

Admission to course, 2 hours CPD, speaker's handout, tea and coffee on arrival, refreshements break during the interval, Certificate of Attendance.

Who should attend? Chiropractors; Osteopaths; Physiotherapists; Podiatrists; Sports Therapists; Hand Therapists; Occupational Therapists

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