Course Search

Find A Masters

1000's of Masters Courses from across the globe

Find An MBA

MBA & Business Masters courses from the World's leading Business Schools

Find A PhD

The World's largest PhD opportunities database

Spotlight

FindA University Ltd Featured Continued Professional Development

Spotlight

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
115554| The Acupuncture Association of Chartered Physiotherapists| AACP Acupuncture Foundation Course - London EC2R - September 2017|

AACP Foundation Acupuncture Course

This course is divided equally between direct contact time and self-directed learning. It is designed to offer participants a level of knowledge, skill and understanding that will allow them to practice acupuncture in a safe and appropriate manner, in a clinical setting.

The course provides a Western medical approach to acupuncture - grounded in current research evidence rather than in traditional Chinese philosophical thinking. This course does not cover the traditional Chinese medical approach to acupuncture, except where Western scientific theory and evidence can be used to explain concepts of traditional Chinese medicine (e.g. fascial planes and meridians).

Participants will be encouraged to critically evaluate their own clinical practice and where appropriate, challenge the current evidence base. This course is designed to provide participants with a rationale for using acupuncture as an adjunctive treatment for the management of common musculoskeletal pain conditions. Topics covered include the laboratory and radiological research which is used to explain the mechanism of acupuncture analgesia; current evidence from acupuncture clinical trials research; and the non-specific "placebo" effects associated with acupuncture analgesia. In addition to needling classical acupuncture points, participants will be introduced to the concept of myofascial trigger points, and the use of acupuncture needling for pain associated with myofascial trigger points.

Students must:

  • have HCPC physiotherapy registration
  • have CSP membership
  • be able to practise acupuncture in a clinical setting between the course parts
  • give the tutor informed consent to receive repetitive needling (with particular regard to being or trying to become pregnant).
  • be able to treat three separate patients in a safe and legal environment for their case studies. Failure to do so may affect your professional HCPC registration. (see AACP website for safety guidelines)
  • attend all 6 days of the course

 

Terms and Conditions apply

115553| Compliance4all| Clinical Trials - Medical Device FDA's Program 2017|

Overview:
The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product.

Why should you Attend:
In spite of the long experience device companies have with clinical trials regulations (published 25 years ago), many companies have found this area an expensive trap. In fact, the only thing more expensive than a good clinical trial is a bad clinical trial.

Areas Covered in the Session:
Introduction
Valid Scientific Evidence
Phases of Device Human Studies
Significant/Non-Significant Risk
IDE Meaning, Content, Review
Exemption from IDE rules

Who Will Benefit:
R&D and Regulatory Staff
Management of R&D Regulatory

Speaker Profile:
Anna Longwell is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics. They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

115552| Compliance4all| Excel Methods - FDA Device Regulations - 2017|

Overview:
FDA regulations cover both the use of workbooks and the creation of electronic records device manufacturers must understand these regulations and their application. The presentation begins with Excel methods to help ensure the spreadsheet produces the results you want.

Why should you Attend:
Excel workbooks must produce correct results, so the first concept helps ensure correctness. Excel workbooks may also cause regulatory problems, because they are easy to implement and very common. Often people that improve processes with these workbooks are not aware of the regulatory requirement.

Areas Covered in the Session:
Understand the pitfalls of using Excel workbooks without a good regulatory plan
Learn methods to recognize the use of Excel workbooks in production or the quality system
Understand Excel workbook tools to help ensure spreadsheets are built correctly
Understand FDA's Part 11 and some of the implications
Learn and apply Part 11 for electronic records

Who Will Benefit:
Quality Engineers
Production and Process Engineers
Manufacturing Engineers
Design Engineers
Purchasing Managers
Purchasing Agents

Speaker Profile:
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

115551| Compliance4all| Medical Devices for Risk Management Techniques 2017|

Overview:
This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

Why should you Attend:
Many companies have even experienced class action law suits because of product quality issues. An effective program of risk management can help you proactively identify and mitigate product risks.

Areas Covered in the Session:
Overview of the ISO14971 standard as it applies to medical device companies
Integrating the new standard with ISO 13485 as part of your overall QMS
Conducting a review of the intended use of your device
Stages of Risk Management as well as Tools and Techniques
Judging the probability that harm may occur from those hazards

Who Will Benefit:
Design Engineer
Manufacturing Engineer
Quality Engineer
R&D Personnel
R&D Project Managers
Quality Managers
Auditors
Regulatory Affairs Specialist
R&D Manager

Speaker Profile:
Susanne Manz MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

115550| Compliance4all| Letters of Credit are issued under the Customs and Practice 2017|

Overview:
Letters of Credit are the primary instruments for assuring payment of goods sold internationally. Letters of Credit are issued under the Uniform Customs and Practice standard and can be negotiated by over 30,000 banks worldwide.

Why should you Attend:
With financing choices that include cash in advance, open terms, letters of credit (L/C), sight drafts and time drafts, both importers and exporters need to understand the true implications of their credit policies and practices.

Areas Covered in the Session:
Gain a Comprehensive Understanding of the Letter of Credit Process
Learn how to Negotiate the Terms of both Import and Export L/Cs
Be 100% aware of Letter of Credit Documentation requirements
Be Aware of all Expenses Associated with Using Letters of Credit

Who Will Benefit:
Exporters
Logistics and Trade Professionals
International Sales Executives
Customs Brokers
Freight Forwarders
Airlines
Steamship Lines
International Banking Personnel

Speaker Profile:
Douglas Cohen has been at the forefront of international trade and transactions. With positions in private law practice, US Department of Commerce, the European Union, IATA, and American Airlines, he has developed significant expertise in import-export operations and compliance, global transactions, international negotiations, intellectual property, and cross-cultural business communication.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

115549| Compliance4all| ISO 14971 Hazard Analysis at Medical Device - 2017|

Overview:
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.

Why should you Attend:
FDA expects that as part of a product development program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is the most powerful of the risk management tools described in ISO 14971 but it is very confusing. Many new concepts are introduced.

Areas Covered in the Session:
Explanation of Hazard Analysis terms
Hazard analysis Process explanation using a template
Examples of terms will be given
Hazard analysis examples will be covered step by step

Who Will Benefit:
Engineer
Engineering Manager
Regulatory Personnel
QA

Speaker Profile:
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

115548| Compliance4all| Laboratory-Developed Tests - Medical devices 2017|

Overview:
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests.

Why should you Attend:
This 1 hour session will explore the reasons FDA has for claiming such jurisdiction, and the objections to FDAs' position articulated by the clinical laboratory community, and others.

Areas Covered in the Session:
"Enforcement Discretion" and how it has been applied to LDT regulation
Extent of CLIA '88 authority over LDT performance
Role of US Congress in answering the question of FDA authority
International (EU) approach to LDTs

Who Will Benefit:
QA Specialist
Complaint Coordinator
Regulatory Specialist
QA Manager
QA Trainer
All above in Medical Device companies

Speaker Profile:
Anna Longwell is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics. They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

115547| Compliance4all| Environmental Monitoring Program at FDA Regulations - 2017|

Overview:
Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring Program fits into the Regulations. Explain the basis of the Four (4) Phases of Clean room transitional monitoring.

Why should you Attend:
The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for Cleaning Validations of your manufacturing equipment?

Areas Covered in the Session:
Applicable Regulations - Where does the EM Program fit in the Regulation? -
Role of Clean room Environmental Monitoring Program?
Basics of Setting a Robust and Effective EM Program - Key Considerations -
Relevant Material Verification Processes - Steps and Content of an EM
Program Testing Procedure

Who Will Benefit:
Quality Control,
Quality Assurance
Microbiologist, Facilities
Chemist, Analysts
Manufacturing

Speaker Profile:
Joy McElroy Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn 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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

115546| Compliance4all| CAPA within a Device Quality System - 2017|

Overview:
You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA this webinar is for you.

Why should you Attend:
Corrective and Preventive Action (CAPA) is the cornerstone of a strong Quality Management System. And yet, many medical device manufacturers struggle to establish and maintain and effective CAPA process.

Areas Covered in the Session:
FDA and NB expectations for CAPA
Lessons Learned from 483s and warning letters
Common problems CAPA
How to structure your CAPA process
How to use IT tools to monitor and maintain your CAPAs
Metrics to ensure your CAPAs are timely and effective
A toolkit for CAPA
Best Practices

Who Will Benefit:
Quality Systems Specialists
Document Control Specialists
Quality and Compliance Specialists
Internal Auditors and Managers
Training Specialists
CAPA Specialists

Speaker Profile:
Susanne Manz MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

115545| Compliance4all| FDA Inspection and Respond to 483 & How to Prepare them - 2017|

Overview:
In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection.

Why should you Attend:
FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483's than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter.

Areas Covered in the Session:
Personnel Preparation
Facility needed to support inspection
Behavior during inspection-what not to sign
Internal/ Mock audits
483 response

Who Will Benefit:
Engineering Personnel
Engineering Management
Quality Management
Corporate Management
Manufacturing Management
Division Management

Speaker Profile:
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

115544| Compliance4all| Validation Program to a Building from Top to Bottom - 2017|

Overview:
Many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build a sustainable validation program.

Why you should attend:
How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program.

Areas Covered In the Session:
Discuss what FDA is really looking for in process validation
Specify the deliverables associated with software validation
Common pitfalls to avoid when executing validation protocols
How to estimate costs and time associated with validation

Who will benefit:
Internal Auditors
Senior Management
Compliance Officers
QA Managers
QC Managers
Purchasing Managers

Speaker Profile:
Jonathan M. Lewis has over twenty-two years’ experience in the areas of executive management, quality control (QC), quality assurance (QA), manufacturing, regulatory affairs, validation, and project management in both industry and consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, dietary supplement, food, and animal food industries.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

115543| Compliance4all| Achieving Compliance Excellence - 2017|

Overview:
We will discuss each of those keys in detail to enhance understanding and to provide the needed information to replicate the approach in your organization.

Why should you Attend:
Because as much as we try, most regulated industries don't have a set approach for developing a compliance program that is integrated into the fabric of their organization, that serves real valuable functions to improve operations, improve and maintain human competence, and enhance competitiveness.

Areas Covered in the Session:
Defining your Critical Processes and why that is important
The Benefits of Developing Sound Regulatory Documentation
Why Harmonizing your Processes is Critical to Consistency in Operations and
Regulatory Compliance

Who Will Benefit:
Directors
Managers
Scientists
Technicians
Associates

Speaker Profile:
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm –
celebrating its twentieth year in business in 2017. Charles has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

115542| Compliance4all| Effective Supplier Qualification Program - 2017|

Overview:
FDA considers the supplier as an extension of your operation. You are liable
for supplier’s conduct. FDA will deal with your company in case of product
failure, especially as related to end user or patient safety concerns.

Areas Covered in the Session:
Learn the pre-selection, selection and assessment process through the use
of various tools
Methods, techniques and strategies that work and are proven with supplier
relations and qualification
Learn how to apply risk-based approaches and why and how to "rank" suppliers
Supplier Agreements, Quality Agreements and other documentation including Audits/Assessments

Who Will Benefit:
QA/QC/Compliance/Regulatory Affairs
Engineering/R&D/Technical Services
Purchasing/Procurement/Sourcing
Consultants

Speaker Profile:
David R. Dills,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

115541| Compliance4all| Cyber Attacks, Beyond Disaster Recovery - 2017|

Overview:
Cyber-attacks and breaches dominate the media and are a significant focus
of the government. Businesses and financial institutions are faced with the
grim reality that a cyber-attack is inevitable. It's not a matter of if an attack
will occur, only when.

Why should you Attend:
A poor response is often more damaging that the cyber-attack itself.
According to recent reports, cyber-attacks cost the average American
business $15.4 million per year, double the global average of $7.7 million.

Areas Covered in the Session:
Cost of a cyber-crime
How a Cyber Incident Response Plan differs from a Disaster Recovery Plan
Components of a Cyber Incident Response Plan
Plan testing
Cyber Incident Response Team Development and obligations
Incident communications
Evaluating solution provider Plans

Who Will Benefit:
Risk Manager
Information Security
Management
Operations

Speaker Profile:
Rayleen M. Pirnie is the founder and owner of RP Payments Risk Consulting
Services, LLC. based in Missouri. She is a nationally recognized payments
risk and fraud expert who offers specialized consulting services, procedural
and risk management reviews, and payments education. Rayleen’s
specialized skill is delving into the world beyond the payment rules; areas
where organizations often find themselves in positions of liability or loss
with little to no clear guidance.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

115540| The Well School| Cupping for Conditions|

Come and join us on this discovery day to learn how to use different chinese cups to treat the common conditions clients present with in our treatment room. Conditions covered will include frozen shoulder, pantasr faciitis, sciatica plus more. 

 

 

Please contact us for more details [email protected]

115539| The Well School| Myofacial Release Massage|

Come and join us to learn how to use the myofacial release massage techniques. Please contact us for more details. 

 

Course is open to all body workers, movement instructors and those wanting to learn more about facsia. 

 

Please email us at [email protected]

115537| The Well School| Diploma in Clinical Organic Aromatherapy|

Professional Organic Aromatherapy Qualification contains four modules, three theory modules and one practical module.

What you will achieve from our course

The course is taught to National Vocational Qualification (NVQ) level 4 and meets the National Occupational Standards and approved by the International Federation of Professional Aromatherapists. IFPA is one of the largest professional Aromatherapy practitioner organisations in the world, an authority in the field of Complementary Medicine with a strong international membership.

On successful completion of the course including the practical and theory examination you will be eligible to join the IFPA as a practising full member, qualified to work as a Clinical Aromatherapist Practitioner in a beauty, natural therapy clinic or set up your own business.

Aromatherapy & Holistic therapies are fast growing complementary therapies, which make this an ideal time to qualify. Aromatherapy Treatments are being offered in some NHS practices, Hospitals, Hospices, Complementary Health Clinics, and Private Medical Clinics.

 

PRE REQUISITES

No previous background in Aromatherapy or massage required.

For those who are interested, it is quite possible to study Aromatherapy without the massage element of the course.

If you are looking to progress with your studies toward a professional qualification, IFPA requires that students also be qualified in Anatomy & Physiology to ITEC, BTEC Level. We offer this course, which can be taken at the same time on either an in-house or distance learning option.

We would need to see proof of any existing A&P qualification in order to be able to award you with the Aromatherapy Diploma and to present to IFPA for your membership.

The Courses must be paid for at the time of booking. You may book each level individually. Prices shown are before value added tax (VAT)

Products are not included, although we offer student discounts on all essential oils, carriers, hydrolats, bases and our range of blended products and kits to support your learning can be bought direct with The Aromatherapy Company.

 

 

THE COURSE SYLLABUS

The Aromatherapy Professional Diploma Course is taught to IFPA standards.

  • The history and philosophy of Aromatherapy
  • The study of over 40 individual essential oils
  • Methods of production; the necessity for quality in essential oils, carriers & hydrolats
  • Safe use, administration & blending of essential oils
  • Aroma-chemistry, the components of essential oils and their synergy
  • The benefits & therapeutic properties of essential oils for the mind body & spirit
  • The philosophy of holistic treatments & complementary therapy
  • Massage techniques and the health benefits of Aromatherapy massage
  • Contra indications and cautions for safe massage practice
  • Client care – confidentiality, communicating effectively appropriately and client record taking
  • Professional conduct, health & safety in the workplace
  • Research skills and professional self development

The guideline for completing all 4 modules (theory and practical) is 9 months, around 6 hours a week, but this is dependent on the package you choose and whether you are studying the massage module. The recommended maximum time for completing all 4 modules is 3 years.

Students must complete all 4 modules to be able to take the final theory & practical examinations. Students must complete all homework, case studies, and assessments and have successfully completed the previous module before embarking on the next.

Students who have already gained a qualification in Massage may be eligible to become a full member of IFPA on a theory only qualification. Your case studies will be using your knowledge of blending and working with your clients with lotions, creams, gels and other uses of organic essential oils.

Our courses are run in line with IFPA Guidelines & Regulations.

The Well School run the Aromatherapy Company courses, who require documented home case study practical sessions, assessments, revision, assignments & research.

Students are entitled to a discounted price on The Aromatherapy Company organic essential oils, carriers, bases, hydrolats and products. A student account will be opened for you upon receipt of payment of your course.

115534| The Well School| Baby Massage Instructor Training|

Come and join us for this two day course

Train to become a baby massage instructor.

Massage is a great combination of touch and attention that babies love. For babies, being massaged by their parents is probably the best remedy for most of their day to day problems. Whether it’s colic, tiredness or tooth ache, baby is distracted with play while the massage produces some of those much needed endorphins.

So, we know the babies will love the massage and if they’re happy, everybody’s happy!

This very practical two-day course will teach you how to instruct groups of parents in why massage is so good and the best way to achieve its benefits

 

Course Description

The remit of the course is to equip therapists who are already skilled in massage and or baby care and have an interest in being able to use massage therapy for the whole family. The specific skill is aimed at instructing parents, grandparents and carers, in how they can all benefit from baby massage.

You will learn;

What babies could be suffering from to cause their pain and crying – safety checks and when to refer

How colic and constipation happen and what parents can do about them.

Why mothers and babies’ reactions to each other are so important and what mums and dads can do to help matters

Baby cues and reactions to stimuli and how we can use those to settle babies

A full teaching routine for conducting a group session, along with a massage sequence, which has worked well for many years.

How to market yourself to various groups through your practice and how to manage a safe and comfortable session for all concerned.

This course has been devised by a tutor with twenty five years’ experience of teaching baby massage to groups of parents and specialising in pregnancy massage. It will show you how to plan for and manage a group teaching environment and it will open up ideas of how to work with other family-related professionals to broaden your market.

30th September & 1st October 2017

115533| The Acupuncture Association of Chartered Physiotherapists| 2 Day Sports Injury Course - Crewe - April 2018|

This two day course is designed for practicing chartered physiotherapists who wish to expand their theoretical knowledge and practical application of acupuncture in the field of sports injuries. The course covers the concepts of homeostasis and its effect on healing and performance and the influence of acupuncture upon soft tissue healing. It also covers a variety of additional advanced needling techniques that can be utilised for the treatment of both acute and chronic sports injuries. Participants should be MCSP and HCPC registered and have already successfully undertaken a recognised acupuncture foundation course.


Aims

  • To develop participant’s theoretical knowledge of acupuncture and its role in the treatment of acute and chronic sports injuries
  • To develop participant’s practical skills in the treatment of a variety of both acute and chronic sports injuries

 

Cost

£180.00 AACP Members

£220.00 Non AACP Members

115532| The Acupuncture Association of Chartered Physiotherapists| AACP Womens Health Course - Crewe - February 2018|

This two day course is designed for practicing chartered physiotherapists who wish to expand their theoretical knowledge and practical application of the use of acupuncture in the treatment of a variety of conditions related to women's health.

The course itself covers both Traditional Chinese and Western medical perspectives in the treatment of a variety of conditions. The course presents a clinical reasoning model for the integration of evidence based acupuncture into physiotherapy practice.

This specialist women's health course is not restricted to physiotherapists only working in women's health as it is of benefit to any physiotherapist wishing to expand their scope of practice into the treatment of conditions within the realms of obstetrics and gynecology.

All participants should be MCSP and HCPC registered and have already successfully undertaken a recognised acupuncture foundation course.

Terms and Conditions apply:

Documents:

115531| MentorHealth| Structuring and Auditing Physician Leases Under the New Stark Rules 2017|

Training Options Duration: 60 Minutes
Tuesday, August 29, 2017 | 10:00 AM PDT | 01:00 PM EDT


Overview: In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 changes. He will also discuss best practices for negotiating and drafting leases on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided.

Why should you Attend: As health care organizations and physicians develop lease arrangements, they must manage their compliance and enterprise risk by ensuring the their leases are defensible under the Stark Law.

Prior to moving forward with any leasing arrangement, the parties should carefully evaluate whether the proposed structure and financial terms support compliance with Stark's technical requirements and key tenets of defensibility so they will be prepared to mount a defense in the event the lease is ever challenged. This webinar will focus on the Stark Law's underlying technical requirements and key tenets of defensibility as they apply to leasing arrangements.

Areas Covered in the Session:

Provide a general Stark Law overview
Examine critical components of Stark compliant leases
Discuss best practices for drafting leases and the related financial terms
Describe best practices for auditing leases
Review processes for documenting fair market value and commercial reasonableness
Discuss best practices for auditing existing leases and potential pitfalls

Who Will Benefit:
In-House Counsel
Health Care Compliance Officers
Health Care Human Resources
Health Care CFO's
Health Care executives

Speaker Profile
Joseph Wolfe is an attorney with Hall, Render, Killian, Heath & Lyman, P.C., the largest health care focused law firm in the country. Mr. Wolfe provides advice and counsel to some of the nation's largest health systems, hospitals and medical groups on a variety of health care issues. He regularly counsels clients on a national basis regarding compliance-focused physician compensation and alignment strategies. He is a frequent speaker on issues related to the physician self-referral statute (Stark Law), hospital-physician transactions, physician compensation governance and health care valuation issues. Before attending law school at the University of Wisconsin, he served as a combat engineer in the United States Army.

Price: $139.00

Contact Info:
Netzealous -MentorHealth
Phone No: 1-800-385-1607
Fax: 302-288-6884
Email: [email protected]
Website: http://www.mentorhealth.com/

115530| MentorHealth| HIPAA Training for the Business Associate|

Training Options Duration: 90 Minutes
Wednesday, August 23, 2017 | 10:00 AM PDT | 01:00 PM EDT

Overview: The objectives of this course will be to go over the specific risks associated with business associates as it relates to HIPAA compliance. 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. Times have changed and unfortunately many businesses are losing clients or unable to get new clients due to problems with their compliance program or lack of a compliance program. I will explain real life scenarios as well as best practices and excellent resources you can use to get your house in order before it's too late.

I will speak on specific experiences from over 17 years in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information and how this ALSO applies to business associates. More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices.

Why should you Attend:

Protect your business
Business associates are now required to comply directly with the HIPAA legislation
Many businesses are losing clients or unable to get clients because of compliance issues

We will be discussing the changes taking place in Washington, DC with the Health and Human Services in relating to business associates and the importance of getting in front of this law rather than waiting until it's too late. 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 - In addition, we will discuss the dangers and liability under HIPAA for being sued. These day's trial attorney's pose a higher risk than the Federal government.

Areas Covered in the Session:
Updates for 2017
What to do if a client requires more than just a signed Business Associate Agreement
How to properly address risks in writing
Fines
Policy and Procedure
Portable Devices
NIST Risk Assessment
Breach Notification
Paperwork that needs to be Updated
Risk Factors

Who Will Benefit:
Any Business Associates who work with Medical Practices or Hospitals (i.e. Billing Companies, Transcription Companies, IT Companies, Answering Services, Home Health, Coders, Attorneys, etc)

Speaker Profile
Brian L Tuttle, CPHIT, CHP, CBRA, Net+, A+, CCNA, MCP is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified Business Resilience Auditor (CBRA) with over 15 years’ experience in Health IT and Compliance Consulting. Mr. Tuttle has worked all of those 15 years with MAG Mutual Healthcare Solutions and is now Senior Compliance Consultant and IT Manager with InGauge Healthcare Solutions (previously named MAG Mutual Healthcare Solutions). 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 .

Price: $139.00

Contact Info:
Netzealous -MentorHealth
Phone No: 1-800-385-1607
Fax: 302-288-6884
Email: [email protected]
Website: http://www.mentorhealth.com/

115529| MentorHealth| Webinar on What All Providers Should Know About This Emerging Payment Model|

Training Options Duration: 60 Minutes
Monday, August 21, 2017 | 10:00 AM PDT | 01:00 PM EDT

Overview: Bundled Payments are becoming more and more recognized as the preferred method of value-based reimbursement by CMS and several other commercial payers. In this presentation this type of payment method will be explained in detail and real-life examples will be given of how bundled payments actually work. In addition, providers will learn ways to optimize their performance under a bundled payment paradigm and how to negotiate bundled service agreements to their best advantage.

Why should you Attend: It is critical for providers to understand the emerging CMS payment models and how these new reimbursement structures affect their organizations. Providers should attend this session to learn how to optimize their performance under a bundled payment paradigm and how to negotiate bundled service agreements to their best advantage.

Areas Covered in the Session:

Explain the key components of bundled payments and how this reimbursement methodology works
Describe the main differences between bundled payments and capitation payments and why one (bundles) is felt to be superior at driving higher value into the healthcare delivery system
List the key capabilities that providers will need to acquire in order to optimize their performance under a bundled payment agreement

Who Will Benefit:
CEO
CFO
COO
President
Vice President
Directors

Speaker Profile
Ellis "Mac" Knight is senior vice president and chief medical officer of Coker Group. With over 30 years in the healthcare arena, he has developed significant experience and knowledge in this industry. Prior to joining Coker, Dr. Knight served as the chief physician and clinical integration officer for Palmetto Health in Columbia, South Carolina, where he oversaw Palmetto Health’s employed physician network and helped to develop and manage their clinical integration program – The Palmetto Health Quality Collaborative. Prior to that, he was Palmetto Health Richland's vice president for medical affairs.

Dr. Knight graduated from Stanford University with a BA degree in Human Biology and received his degree, cum laude, in medicine from the University of Oregon Health Science Center's School of Medicine. He earned an MBA from the University of Massachusetts at Amherst and holds fellowships in the American College of Physicians, the Society of Hospital Medicine and the American College of Healthcare Executives.

Dr. Knight oversees Coker Group’s hospital strategy and operations services and serves as Coker Group’s chief medical officer. He has a special interest and expertise in population health management, clinical care process design, cost accounting and hospital – physician integration.

Price: $139.00

Contact Info:
Netzealous -MentorHealth
Phone No: 1-800-385-1607
Fax: 302-288-6884
Email: [email protected]
Website: http://www.mentorhealth.com/

115528| MentorHealth| HIPAA Hybrid Entities - What If Healthcare is Only a Part of What You Do|

Training Options Duration: 90 Minutes
Thursday, August 17, 2017 | 10:00 AM PDT | 01:00 PM EDT

Overview: Many organizations that provide health care services also provide other services that are not related to heath care and are that not paid for by health plans or Medicaid. For such organizations a decision must be made: Do we apply HIPAA controls and policies throughout the organization for all programs, or do we decide what parts of our organization are under HIPAA and what parts are not, and designate Hybrid Entity status under HIPAA? There are significant impacts in making the choice to be a Hybrid Entity or not, and entities need to consider their own particular circumstances to determine the most appropriate path to take.

If one portion of an entity is covered under HIPAA, the entire entity is subject to HIPAA, unless the entity declares Hybrid Entity status and limits the sharing of information between the HIPAA and non-HIPAA portions. Either option has its pros and cons and any entity's choice is not obvious at first glance. For something like a county government, it's easy to see that while the County Nursing Home may be a HIPAA entity, it would not make sense to apply HIPAA controls to the County Highway Department, and the designation of Hybrid Entity status for the county would an obvious choice, as there is no need to share any health care information between the County Nursing Home and the County Highway Department.

But for behavioral health and social service organizations, the choice is not so clear. To be able to share information from a HIPAA portion to a non-HIPAA portion, in a Hybrid you need to have a HIPAA Authorization from each individual served, and you must have strict logical "firewalls" between the HIPAA and non-HIPAA portions to protect information from unauthorized access. You need to make sure any systems that carry or touch any Protected Health Information are secure no matter which model you follow would it be easier to apply HIPAA throughout the organization? You do, after all, have obligations to protect individuals' privacy, ethically or under the law, whether HIPAA applies or not, and HIPAA provides a good, recognized standard for protecting the privacy and security or personal information. And consistency within the organization is important - wherever you can reduce staff choices in how to handle information, you reduce the chances for making the wrong choice.

There are burdens associated with either choice, and the best choice depends on how you do business and how easily separable and distinct your programs are. If there is no real overlap between HIPAA and non-HIPAA programs in services, locations, and staff, Hybrid status may make sense, but you will need to get a HIPAA Authorization if you want to refer an individual to another of your programs outside of HIPAA. If the lines are blurred and information needs to be shared to achieve the organization's goals, HIPAA-everywhere may be better, but it will require organization-wide policies, procedures, and training. This session will examine the options and the issues in choosing to be a Hybrid Entity or not and assist organizations in making the decision and implementing the results of the decision. Agencies will come away with a better understanding of how they should designate themselves and what they need to do for compliance in either case.

In This Session:

The definition of a HIPAA Hybrid Entity
Typical Hybrid Entities
Understanding your information flows
How much of your work is healthcare?
Requirements of not claiming Hybrid status
Requirements of claiming Hybrid status
The HIPAA Authorization issue
Example Hybrid Entity analyses
Policy and Procedure Requirements
Documentation and Training Requirements

Why should you Attend: Recent HIPAA enforcement settlements indicate the importance of properly designating Hybrid Entity status. UMass paid a $650,000 settlement amount, reflective of the fact that the University operated at a loss in 2015, for not adequately identifying all the HIPAA covered elements of UMass activities and improperly designating its Hybrid Entity status. Skagit County, Washington also settled with HHS after they had not properly designated the county as a Hybrid Entity due to its County Health Department activities.

No matter whether the organization takes the steps to declare Hybrid Entity status or to implement HIPAA organization-wide, there are significant implementation, policy, and training impacts to consider. Going Hybrid means having a clear separation of health information from other information outside the HIPAA-covered portion, and no sharing of PHI outside the HIPAA portion with other portions of the organization in order to coordinate services can take place without having HIPAA Authorizations in place. If the organization chooses to take the HIPAA-everywhere approach, HIPAA policies, procedures, and training will have to be applied organization-wide, but sharing information within the organization in order to better deliver services is much easier. There are pros and cons to either choice, and the best choice depends on how the organization does business and the services it provides.

Areas Covered in the Session:
Find out how to evaluate whether or not your organization is best served by Hybrid Entity status
Learn how to properly declare and document Hybrid Entity status when that is the best choice
Find out what policies and procedures are required, and for whom, for entities using a HIPAA-everywhere approach
Find out what policies and procedures are required, and for whom, for entities using a HIPAA-Hybrid approach
Learn about the training and education that must take place and be documented to ensure your staff uses health information properly and does not risk exposure of PHI
Find out the steps that must be followed in the event of a breach of PHI
Learn about how the HIPAA audit and enforcement activities are now being increased and how you must be prepared or risk significant penalties

Who Will Benefit:
Compliance Director
CEO
CFO
Privacy Officer
Security Officer
Information Systems Manager
HIPAA Officer
Chief Information Officer
Health Information Manager
Healthcare Counsel/Lawyer
Office Manager

Speaker Profile
Jim Sheldon-Dean is the founder and director of compliance services at Lewis Creek Systems, LLC, a Vermont-based consulting firm founded in 1982, providing information privacy and security regulatory compliance services to a wide variety of health care entities.

Sheldon-Dean serves on the HIMSS Information Systems Security Workgroup, has co-chaired the Workgroup for Electronic Data Interchange Privacy and Security Workgroup, and is a recipient of the WEDI 2011 Award of Merit. He is a frequent speaker regarding HIPAA and information privacy and security compliance issues at seminars and conferences, including speaking engagements at numerous regional and national healthcare association conferences and conventions and the annual NIST/OCR HIPAA Security Conference in Washington, D.C.

Sheldon-Dean has more than 30 years of experience in policy analysis and implementation, business process analysis, information systems and software development. His experience includes leading the development of health care related Web sites; award-winning, best-selling commercial utility software; and mission-critical, fault-tolerant communications satellite control systems. In addition, he has eight years of experience doing hands-on medical work as a Vermont certified volunteer emergency medical technician. Sheldon-Dean received his B.S. degree, summa cum laude, from the University of Vermont and his master’s degree from the Massachusetts Institute of Technology.

Price: $139.00

Contact Info:
Netzealous -MentorHealth
Phone No: 1-800-385-1607
Fax: 302-288-6884
Email: [email protected]
Website: http://www.mentorhealth.com/

115527| MentorHealth| HIPAA Covered Entities: Managing the HIPAA Business Associate Process|

Training Options Duration: 60 Minutes
Monday, August 14, 2017 | 10:00 AM PDT | 01:00 PM EDT

Overview: The webinar will cover how to find out if business associates have the necessary technical, physical and administrative safeguards in place to protect shared protected health information. The webinar will address when a vendor becomes a business associate and how that relationship may change the dynamics.

Understanding the Business Associate Agreement (BAA) process and making sure all ten government mandated requirements are in place will be covered. Find out about the use of Vendor Security Questionnaires and how to implement. The webinar will cover breaches caused by business associates and how to handle such an occurrence. If your healthcare organization needs to understand what your responsibilities are in managing business associates, please join us for this informative and interactive course

Why should you Attend: If you are a healthcare organization that has vendors providing services as a HIPAA Business Associate, managing this process can be confusing. A "business associate" is a person or entity that performs certain functions or activities that involve the use or disclosure of protected health information on behalf of, or provides services to, a covered entity healthcare provider. Having a systematic process to handle these business relationships to ensure a healthcare organization's protected health information is being properly accessed and protected by the business associate is critical. Organizations must know how to identify business associates. Business associate functions and activities include claims processing or administration data analysis, processing or administration; utilization review quality assurance billing benefit management practice management and repricing. Business associate services are: legal actuarial accounting consulting data aggregation; management administrative accreditation and financial.

Areas Covered in the Session:

How to conduct Vendor Screening
Ten Requirements of Business Associate Agreement
Developing and Using Vendor Security Questionnaires
Reviewing the Questionnaires
I Like This Vendor,but
Auditing Your Business Associate
Dealing with a Breach Caused by Your Business Associate
What are the penalties and fines for non-compliance and how to avoid them?
Q&A

Who Will Benefit:
Compliance Officer
HIPAA Privacy Officer
HIPAA Security Officer
Medical/Dental Office Managers
Practice Managers
Information Systems Manager
Chief Information Officer
General Counsel/Lawyer
Practice Management Consultants

Speaker Profile
Jay Hodes president of Colington Security Consulting, LLC, which provides HIPAA consulting services for healthcare providers and business associates. Mr. Hodes has over 30 years of combined experience in risk assessments, site security evaluation, regulatory compliance, policy and procedures assessments, and federal law enforcement management. He is the former Assistant Inspector General for Investigations at the U.S. Department of Health and Human Services.

Mr. Hodes has been the keynote speaker and provided presentations regarding HIPAA compliance to a number of professional healthcare organizations. He has published over 30 educational articles regarding HIPAA compliance, been featured in Part B news articles and provided a guest post for the Electronic Health Reporter.

Price: $139.00

Contact Info:
Netzealous -MentorHealth
Phone No: 1-800-385-1607
Fax: 302-288-6884
Email: [email protected]
Website: http://www.mentorhealth.com/

115526| MentorHealth| HIPAA and the Compliance Officer|

Training Options Duration: 90 Minutes
Wednesday, August 9, 2017 | 10:00 AM PDT | 01:00 PM EDT

Overview: This webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. Areas also 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 litigated cases I have worked where HIPAA is being used to justify state cases of negligence -THIS IS BECOMING A HUGE RISK! In addition, this course will cover the highest risk factors for being sued as well as being audited (these two items tend to go hand in hand).

Why should you Attend:

Do you have an affective HIPAA compliance program?
New laws and funding mean increased risk for both business associates and covered entities
HIPAA Omnibus - Do you know what's involved and what you need to do?
What does Omnibus mean for covered entities and business associates?
Why should you be concerned?
Court cases that are changing the landscape of HIPAA and patient's ability to sue
TRIAL ATTORNEYS ARE MORE DANGEROUS THAN THE FEDERAL GOVERNMENT

It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to what we need to do as compliance officers. You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT or internal administrative practices.

Areas Covered in the Session:
Updates for 2017
Requirements of Compliance Officers
Real life litigated cases
BYOD
Portable Devices
Business Associates and the increased burden
Emailing of PHI
Texting of PHI
Federal Audit Process
HIPAA and Suing how this works
Risk Assessment
Best Resources

Who Will Benefit:
Practice Managers
Any Business Associates who work with Medical Practices or Hospitals (i.e. Billing Companies, Transcription Companies, IT Companies, Answering Services, Home Health, Coders, Attorneys, etc)
MD's and other Medical Professionals

Speaker Profile
Brian L Tuttle, CPHIT, CHP, CBRA, Net+, A+, CCNA, MCP is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified Business Resilience Auditor (CBRA) with over 15 years’ experience in Health IT and Compliance Consulting. Mr. Tuttle has worked all of those 15 years with MAG Mutual Healthcare Solutions and is now Senior Compliance Consultant and IT Manager with InGauge Healthcare Solutions (previously named MAG Mutual Healthcare Solutions). 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 .

Price - $139

Contact Info:
Netzealous -MentorHealth
Phone No: 1-800-385-1607
Fax: 302-288-6884
Email: [email protected]
Website: http://www.mentorhealth.com/

 

115525| MentorHealth| Webinar on Structuring and Auditing Physician Employment Agreements: Key Stark Law Considerations by Joseph Wolfe|

Training Options Duration: 60 Minutes
Tuesday, August 8, 2017 | 10:00 AM PDT | 01:00 PM EDT
Overview: In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 changes. He will also discuss best practices for negotiating and drafting employment agreements on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided.

Why should you Attend: As health care organizations and physicians develop employment arrangements, they must manage their compliance and enterprise risk by ensuring the employment is defensible under the Stark Law. Prior to moving forward with any employment arrangement, the parties should carefully evaluate whether the proposed structure and financial terms support compliance with Stark's technical requirements and key tenets of defensibility so they will be prepared to mount a defense in the event the arrangement is ever challenged. This webinar will focus on the Stark Law's underlying technical requirements and key tenets of defensibility as they apply to physician employment arrangements.

Areas Covered in the Session:

Provide a general Stark Law overview
Examine critical components of Stark compliant employment arrangements
Discuss best practices for drafting employment agreements and the related financial terms
Describe best practices for auditing employment agreements
Review processes for documenting fair market value and commercial reasonableness
Discuss best practices for auditing existing arrangements and potential pitfalls

Who Will Benefit:
In-House Counsel
Health Care Compliance Officers
Health Care Human Resources
Health Care CFO's
Health Care executives

Speaker Profile
Joseph Wolfe is an attorney with Hall, Render, Killian, Heath & Lyman, P.C., the largest health care focused law firm in the country. Mr. Wolfe provides advice and counsel to some of the nation's largest health systems, hospitals and medical groups on a variety of health care issues. He regularly counsels clients on a national basis regarding compliance-focused physician compensation and alignment strategies. He is a frequent speaker on issues related to the physician self-referral statute (Stark Law), hospital-physician transactions, physician compensation governance and health care valuation issues. Before attending law school at the University of Wisconsin, he served as a combat engineer in the United States Army.

Price: $139.00

Contact Info:
Netzealous -MentorHealth
Phone No: 1-800-385-1607
Fax: 302-288-6884
Email: [email protected]
Website: http://www.mentorhealth.com/

 

115524| The Acupuncture Association of Chartered Physiotherapists| 2 Day Refresher Course - Crewe - February 2018|

This two day course is designed for chartered physiotherapists who have previously undertaken a recognised acupuncture foundation course and wish to refresh their practical skills in the clinical treatment of both acute and chronic musculoskeletal pain. Day one covers a review of the analgesic mechanisms of acupuncture, the health and safety implications including contraindication and precautions as well as discussion regarding the concept of the layering technique related to physiological mechanisms and clinical reasoning. Practical aspects of the day will cover the needling of the most common acupuncture points utilised in clinical practice. Day two will take the knowledge from day one and build on the understanding of prescriptions and treatment design. Incorporating the points revised during the previous session, treatment for common conditions both by pathology and region will be discussed in theory and then needled practically. There is also the option of an admissions assessment at the end of day two to enable attendees to attain AACP membership if required. The course delivers 14 hours approved CPD. Participants should be MCSP and HCPC registered and have already successfully undertaken a recognised acupuncture foundation course.

Cost: £190.00 AACP Members, £260.00 non-AACP members

Please log in to receive the member price

Terms & Conditions apply

115519| Multiple Locations| European Regulatory Procedures 2017|

 

Overview:

 

  • EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines.
  • In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines.
  • EMA's success is based on cooperation within the European medicines regulatory network - a unique partnership between the European Commission, the medicines regulatory authorities in the European Economic Area countries, and EMA. Working together has encouraged the exchange of knowledge, ideas and best practices, to ensure the highest standards in medicines regulation.
  • Today, seven EMA scientific committees and more than 30 working parties provide scientific expertise for the regulation of medicines by drawing on a pool of several thousand European scientific experts from the network.
  • And Much More...

 

Why should you attend:

 

  • What is EMA and the overall process with CP, MRP, DCP and other interactions with agencies?
  • Identify the challenges to global submissions management presented by EU versus US key differences
  • Understand the EU legislative environment and the key EU Directives and Regulations relating to human medicines and for strategic regulatory intelligence decision-making
  • Identify and address challenges and pain points to the global submissions management process and making critical regulatory decisions based on EU versus US differences
  • Demonstrate knowledge on navigating the regulatory process through EMA regulations and inspection guidelines regarding submissions
  • Learn more about and how to apply the different types of procedures for authorization
  • If "full/usual" authorization not possible, several options exist

 

Areas Covered in the Session:

 

  • EMA and many NCAs are involved in the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S), a close international cooperation between pharmaceutical inspection authorities in the field of GMP.
  • The legal basis and main features of the various types of authorizations
  • Evaluate the various options for the submission of a marketing authorization application for regulatory strategy for the compound in the EU
  • As a bonus, identify the necessary steps needed to prepare for, and survive, an EMA inspection

 

Who Will Benefit:

 

This seminar will provide an overview and in-depth snapshot of the regulatory process with EMA and other regulatory authorities. Individuals desiring a comprehensive overview of the regulatory filing requirements in Europe, including personnel within Regulatory Affairs in the pharmaceutical, biopharmaceutical and generic drug industries, as well as experienced professionals requiring a "refresh" will find this seminar beneficial. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the EMA and regulatory process, including:

  • Clinical Research Associates
  • Clinical Project Managers
  • Regulatory Affairs Professionals
  • Clinical Investigators and Clinical Research Coordinators
  • Regulatory Affairs Management
  • Regulatory Affairs Specialist
  • Auditors
  • Compliance Specialist
  • Clinical Affairs
  • Quality Assurance Management
  • Consultants

 

 

Agenda:

 

 

Day 1 Schedule

 

Lecture 1: EMA and Regulatory Overview and Pathways

  • Introductions and Background
  • Legal Basis for the European Regulation of Medicinal Products
  • EU Pharmaceutical Legislation Overview
  • Review of the key EU Directives and Regulations
  • Legal and Regulatory basis of marketing authorization applications
  • Main features of the EU Marketing Authorization (MA) process and next steps
  • How the EMA, EU institutions and individual national health authorities interact
  • Identify and describe the scope, operation and management of the Centralized Procedure (CP) and other aspects of the CP
  • Mutual Recognition (MRP) and Decentralized Procedure (DCP) and factors directly influencing the choice of procedure and your regulatory pathway
  • MRP is based on the mutual recognition by CMSs of a national MA granted by a RMS
  • DCP is available for new products which have not yet been authorized in any EEA country and do not fall within the mandatory scope of the CP
  • Review and navigation of key EU regulatory websites
  • European Commission (EC), EMA and interrelationship with European Directorate for the Quality of Medicines (EDQM)
  • National Competent Authorities and interactions with other regulatory bodies
  • Regulatory Pathways to consider regarding the Centralized Procedure
  • Prepare and handle effective Consultations with EMA and your pre-submission activities
  • Managing your procedural phases up to acceptance of the final CHMP opinion and preparing for next steps in the regulatory process

 

Lecture 2: Exercise and Recap of Day 1

  • Interactive Discussions
  • Review of Regulatory Documents

Day 2 Schedule

Lecture 1: EMA and Agencies

  • Reviewing and addressing Decentralized and Mutual Recognition Procedures
  • Main features and attributes as well as differences of DCP and MRP
  • Addressing Variations to the EU Marketing Authorization and Post-Approval Changes
  • Overview and vital elements of the variations procedure and dealing with implementing guidelines and other materials
  • EU Regulatory Innovations for Specific Groups of Products and having a viable regulatory pathway for Orphan Drugs, Herbal Medicinal products and others
  • Developing trends and the short and long-term impact on the EU pharmaceutical registration process
  • Accelerated Assessments and Conditional Approvals and other Considerations

Lecture 2: Exercise and Recap of Day 2

  • Interactive Discussions
  • Review of Regulatory Documents

Lecture 3: Debrief/Adjourn

  • Recap of topics and key discussion points and take away message
  • FAQs and latest trends

 

Speaker

David R. Dills

Global Regulatory Affairs & Compliance Consultant 

David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness. He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency-EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company's commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing. He recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore's Who's Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills' academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ's Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.

 

Location:  Zurich, Switzerland Date:  August 28th & 29th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  Hilton Zurich Airport   Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

Price:

 

Register now and save $200. (Early Bird)

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

Until July 15, Early Bird Price: $1,695.00 From July 16 to August 26, 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=900984SEMINAR?findcpd-August-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

 

 

 

115520| Multiple Locations| European Regulatory Procedures 2017|

 

Overview:

 

  • EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines.
  • In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines.
  • EMA's success is based on cooperation within the European medicines regulatory network - a unique partnership between the European Commission, the medicines regulatory authorities in the European Economic Area countries, and EMA. Working together has encouraged the exchange of knowledge, ideas and best practices, to ensure the highest standards in medicines regulation.
  • Today, seven EMA scientific committees and more than 30 working parties provide scientific expertise for the regulation of medicines by drawing on a pool of several thousand European scientific experts from the network.
  • And Much More...

 

Why should you attend:

 

  • What is EMA and the overall process with CP, MRP, DCP and other interactions with agencies?
  • Identify the challenges to global submissions management presented by EU versus US key differences
  • Understand the EU legislative environment and the key EU Directives and Regulations relating to human medicines and for strategic regulatory intelligence decision-making
  • Identify and address challenges and pain points to the global submissions management process and making critical regulatory decisions based on EU versus US differences
  • Demonstrate knowledge on navigating the regulatory process through EMA regulations and inspection guidelines regarding submissions
  • Learn more about and how to apply the different types of procedures for authorization
  • If "full/usual" authorization not possible, several options exist

 

Areas Covered in the Session:

 

  • EMA and many NCAs are involved in the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S), a close international cooperation between pharmaceutical inspection authorities in the field of GMP.
  • The legal basis and main features of the various types of authorizations
  • Evaluate the various options for the submission of a marketing authorization application for regulatory strategy for the compound in the EU
  • As a bonus, identify the necessary steps needed to prepare for, and survive, an EMA inspection

 

Who Will Benefit:

 

This seminar will provide an overview and in-depth snapshot of the regulatory process with EMA and other regulatory authorities. Individuals desiring a comprehensive overview of the regulatory filing requirements in Europe, including personnel within Regulatory Affairs in the pharmaceutical, biopharmaceutical and generic drug industries, as well as experienced professionals requiring a "refresh" will find this seminar beneficial. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the EMA and regulatory process, including:

  • Clinical Research Associates
  • Clinical Project Managers
  • Regulatory Affairs Professionals
  • Clinical Investigators and Clinical Research Coordinators
  • Regulatory Affairs Management
  • Regulatory Affairs Specialist
  • Auditors
  • Compliance Specialist
  • Clinical Affairs
  • Quality Assurance Management
  • Consultants

 

 

Agenda:

 

 

Day 1 Schedule

 

Lecture 1: EMA and Regulatory Overview and Pathways

  • Introductions and Background
  • Legal Basis for the European Regulation of Medicinal Products
  • EU Pharmaceutical Legislation Overview
  • Review of the key EU Directives and Regulations
  • Legal and Regulatory basis of marketing authorization applications
  • Main features of the EU Marketing Authorization (MA) process and next steps
  • How the EMA, EU institutions and individual national health authorities interact
  • Identify and describe the scope, operation and management of the Centralized Procedure (CP) and other aspects of the CP
  • Mutual Recognition (MRP) and Decentralized Procedure (DCP) and factors directly influencing the choice of procedure and your regulatory pathway
  • MRP is based on the mutual recognition by CMSs of a national MA granted by a RMS
  • DCP is available for new products which have not yet been authorized in any EEA country and do not fall within the mandatory scope of the CP
  • Review and navigation of key EU regulatory websites
  • European Commission (EC), EMA and interrelationship with European Directorate for the Quality of Medicines (EDQM)
  • National Competent Authorities and interactions with other regulatory bodies
  • Regulatory Pathways to consider regarding the Centralized Procedure
  • Prepare and handle effective Consultations with EMA and your pre-submission activities
  • Managing your procedural phases up to acceptance of the final CHMP opinion and preparing for next steps in the regulatory process

 

Lecture 2: Exercise and Recap of Day 1

  • Interactive Discussions
  • Review of Regulatory Documents

Day 2 Schedule

Lecture 1: EMA and Agencies

  • Reviewing and addressing Decentralized and Mutual Recognition Procedures
  • Main features and attributes as well as differences of DCP and MRP
  • Addressing Variations to the EU Marketing Authorization and Post-Approval Changes
  • Overview and vital elements of the variations procedure and dealing with implementing guidelines and other materials
  • EU Regulatory Innovations for Specific Groups of Products and having a viable regulatory pathway for Orphan Drugs, Herbal Medicinal products and others
  • Developing trends and the short and long-term impact on the EU pharmaceutical registration process
  • Accelerated Assessments and Conditional Approvals and other Considerations

Lecture 2: Exercise and Recap of Day 2

  • Interactive Discussions
  • Review of Regulatory Documents

Lecture 3: Debrief/Adjourn

  • Recap of topics and key discussion points and take away message
  • FAQs and latest trends

 

Speaker

David R. Dills

Global Regulatory Affairs & Compliance Consultant 

David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness. He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency-EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company's commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing. He recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore's Who's Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills' academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ's Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.

 

Location:  Zurich, Switzerland Date:  August 28th & 29th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  Hilton Zurich Airport   Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

Price:

 

Register now and save $200. (Early Bird)

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

Until July 15, Early Bird Price: $1,695.00 From July 16 to August 26, 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=900984SEMINAR?findcpd-August-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

 

 

 

Find CPD

Copyright ©2005-2017
All rights reserved

Find CPD is a database of Continuing Professional Development (CPD) Courses in the UK

FindA University Ltd, Sellers Wheel, 151 Arundel Street, Sheffield, S1 2NU, UK. Tel: +44 (0)114 268 4940 Fax: +44 (0) 114 268 5766
Cookie Policy    X