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FindA University Ltd Featured Continued Professional Development

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Latest CPD Courses
126231| Multiple Locations| HIPAA Privacy, Security and Breach Notification Compliance 2017|

 

Overview:

 

This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates.

The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate.

Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided.

 

Who Will Benefit: 

  • Information Security Officers
  • Risk Managers
  • Compliance Officers
  • Privacy Officers
  • Health Information Managers
  • Information Technology Managers
  • Medical Office Managers
  • Chief Financial Officers
  • Systems Managers
  • Legal Counsel
  • Operations Directors

 

 

Agenda:

Day 1 Schedule

 

 

Day one sets the stage with an overview of the HIPAA regulations and then continues with presentation of the specifics of the Privacy Rule, recent changes to the rules, and the basics of the Security Rule

Lecture 1:

Overview of HIPAA Regulations

  • The Origins and Purposes of HIPAA
  • Privacy Rule History and Objectives
  • Security Rule History and Objectives
  • Breach Notification Requirements, Benefits, and Results

Lecture 2:

HIPAA Privacy Rule Principles, Policies and Procedures

  • Patient Rights under HIPAA
  • Limitations on Uses and Disclosures
  • Required Policies and Procedures
  • Training and Documentation Requirements

Lecture 3:

Recent and Proposed Changes to the HIPAA Rules

Lecture 4:

HIPAA Security Rule Principles

  • General Rules and Flexibility Provisions
  • The Role of Risk Analysis
  • Security Safeguards
  • Training and Documentation

 Day 2 Schedule

 

Day two begins with a detailed examination of HIPAA Security Rule requirements and what must be done to survive audits by the US Department of Health and Human Services, including an examination of how risk analysis can be used to drive compliance by the systematic examination of information flows and mitigation of risks discovered, and an exploration of the official HHS HIPAA Audit Protocol, including how to use the protocol to help manage your compliance work and its documentation. Finally, the day concludes with a session on the essential activities of documenting policies, procedures, and activities, training staff and managers in the issues and policies they need to know about, and examining compliance readiness through drills and self-audits.

Lecture 1:

HIPAA Security Policies and Procedures and Audits

  • HIPAA Security Policy Framework
  • Sample Security Policy Content
  • Recommended Level of Detail for Policies and Procedures
  • The New HIPAA Compliance Audit Protocol

Lecture 2:

Risk Analysis for Security and Meaningful Use

Lecture 3:

Risk Mitigation and Compliance Remediation

  • Typical Security Risks
  • Social Media, Texting, e-mail, and Privacy
  • Dealing with Portable Devices and Remote Access
  • Compliance Planning

Lecture 4:

Documentation, Training, Drills and Self-Audits

  • How to Organize and Use Documentation to Your Advantage
  • Training Methods and Compliance Improvement
  • Conducting Drills in Incident Response
  • Using the HIPAA Audit Protocol for Documentation and Self-Auditing

 

 

Speaker

Jim Sheldon Dean

Director of Compliance Services, Lewis Creek Systems, LLC 

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.

                

 

Location: Chicago, ILDate:  November 30th & December 1st, 2017 and Time: 9:00 AM to 6:00 PM

Venue:   WILL BE ANNOUNCED SOON, Chicago, IL

 

Price:

 

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

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

Register now and save $200. (Early Bird)

Until October 20, Early Bird Price: $1,295.00 From October 21 to November 28, Regular Price: $1,495.00

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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901357SEMINAR?findcpd-November-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

 

126232| Multiple Locations| HIPAA Privacy, Security and Breach Notification Compliance 2017|

 

Overview:

 

This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates.

The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate.

Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided.

 

Who Will Benefit: 

  • Information Security Officers
  • Risk Managers
  • Compliance Officers
  • Privacy Officers
  • Health Information Managers
  • Information Technology Managers
  • Medical Office Managers
  • Chief Financial Officers
  • Systems Managers
  • Legal Counsel
  • Operations Directors

 

 

Agenda:

Day 1 Schedule

 

 

Day one sets the stage with an overview of the HIPAA regulations and then continues with presentation of the specifics of the Privacy Rule, recent changes to the rules, and the basics of the Security Rule

Lecture 1:

Overview of HIPAA Regulations

  • The Origins and Purposes of HIPAA
  • Privacy Rule History and Objectives
  • Security Rule History and Objectives
  • Breach Notification Requirements, Benefits, and Results

Lecture 2:

HIPAA Privacy Rule Principles, Policies and Procedures

  • Patient Rights under HIPAA
  • Limitations on Uses and Disclosures
  • Required Policies and Procedures
  • Training and Documentation Requirements

Lecture 3:

Recent and Proposed Changes to the HIPAA Rules

Lecture 4:

HIPAA Security Rule Principles

  • General Rules and Flexibility Provisions
  • The Role of Risk Analysis
  • Security Safeguards
  • Training and Documentation

 Day 2 Schedule

 

Day two begins with a detailed examination of HIPAA Security Rule requirements and what must be done to survive audits by the US Department of Health and Human Services, including an examination of how risk analysis can be used to drive compliance by the systematic examination of information flows and mitigation of risks discovered, and an exploration of the official HHS HIPAA Audit Protocol, including how to use the protocol to help manage your compliance work and its documentation. Finally, the day concludes with a session on the essential activities of documenting policies, procedures, and activities, training staff and managers in the issues and policies they need to know about, and examining compliance readiness through drills and self-audits.

Lecture 1:

HIPAA Security Policies and Procedures and Audits

  • HIPAA Security Policy Framework
  • Sample Security Policy Content
  • Recommended Level of Detail for Policies and Procedures
  • The New HIPAA Compliance Audit Protocol

Lecture 2:

Risk Analysis for Security and Meaningful Use

Lecture 3:

Risk Mitigation and Compliance Remediation

  • Typical Security Risks
  • Social Media, Texting, e-mail, and Privacy
  • Dealing with Portable Devices and Remote Access
  • Compliance Planning

Lecture 4:

Documentation, Training, Drills and Self-Audits

  • How to Organize and Use Documentation to Your Advantage
  • Training Methods and Compliance Improvement
  • Conducting Drills in Incident Response
  • Using the HIPAA Audit Protocol for Documentation and Self-Auditing

 

 

Speaker

Jim Sheldon Dean

Director of Compliance Services, Lewis Creek Systems, LLC 

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.

                

 

Location: Chicago, ILDate:  November 30th & December 1st, 2017 and Time: 9:00 AM to 6:00 PM

Venue:   WILL BE ANNOUNCED SOON, Chicago, IL

 

Price:

 

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

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

Register now and save $200. (Early Bird)

Until October 20, Early Bird Price: $1,295.00 From October 21 to November 28, Regular Price: $1,495.00

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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901357SEMINAR?findcpd-November-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

 

126229| Multiple Locations| Auditing Analytical Laboratories for FDA Compliance|

 

Course "Auditing Analytical Laboratories for FDA Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

 

Who will benefit:

 

The following specific types of workers will benefit from this webinar:

  • External and Internal Auditors
  • Supervisors and Analysts in Quality Control Laboratories and Quality Assurance groups
  • Supervisors and Analysts in Contract Testing Laboratories
  • Personnel Responsible for Selecting Contract Testing Laboratories
  • Consultants

 

Agenda:

 

 

Day 1 Schedule

 

Lecture 1:

GMP Regulations that Apply to Analytical Laboratories

Lecture 2:

Reviewing Documentation

Lecture 3:

Advance Preparation for the Audit

Lecture 4:

Auditing Styles and Structures

 

Day 2 Schedule 

Lecture 1:

Equipment and Laboratory Instrument Qualification

Lecture 2:

What to look for while doing a Walk-Through

Lecture 3:

Other Regulations and Standards, including ISO 17025

Lecture 4:

Following through on the Audit

 

 

Speaker

Dr. Steven Kuwahara

Founder & Principal, GXP Biotechnology, LLC

Dr. Steven Kuwahara, Ph.D. is the Founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories. Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.

               

 

 

 Location: Manila, Philippines Date:  November 20th & 21st, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  WILL BE ANNOUNCED SOON, Manila, Philippines

 

 

 

Price:

 

Price: $895.00 (Seminar Fee for One Delegate)

Register for 5 attendees   Price: $2,685.00   $4,475.00 You Save: $1,790.00 (40%)*

Register now and save $200. (Early Bird)

Until October 10, Early Bird Price: $895.00 From October 11 to November 18, Regular Price: $1,095.00

Register for 10 attendees   Price: $4,922.00  $8,950.00 You Save: $4,028.00 (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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901324SEMINAR?findcpd-November-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

 

 

 

126230| Multiple Locations| Auditing Analytical Laboratories for FDA Compliance|

 

Course "Auditing Analytical Laboratories for FDA Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

 

Who will benefit:

 

The following specific types of workers will benefit from this webinar:

  • External and Internal Auditors
  • Supervisors and Analysts in Quality Control Laboratories and Quality Assurance groups
  • Supervisors and Analysts in Contract Testing Laboratories
  • Personnel Responsible for Selecting Contract Testing Laboratories
  • Consultants

 

Agenda:

 

 

Day 1 Schedule

 

Lecture 1:

GMP Regulations that Apply to Analytical Laboratories

Lecture 2:

Reviewing Documentation

Lecture 3:

Advance Preparation for the Audit

Lecture 4:

Auditing Styles and Structures

 

Day 2 Schedule 

Lecture 1:

Equipment and Laboratory Instrument Qualification

Lecture 2:

What to look for while doing a Walk-Through

Lecture 3:

Other Regulations and Standards, including ISO 17025

Lecture 4:

Following through on the Audit

 

 

Speaker

Dr. Steven Kuwahara

Founder & Principal, GXP Biotechnology, LLC

Dr. Steven Kuwahara, Ph.D. is the Founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories. Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.

               

 

 

 Location: Manila, Philippines Date:  November 20th & 21st, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  WILL BE ANNOUNCED SOON, Manila, Philippines

 

 

 

Price:

 

Price: $895.00 (Seminar Fee for One Delegate)

Register for 5 attendees   Price: $2,685.00   $4,475.00 You Save: $1,790.00 (40%)*

Register now and save $200. (Early Bird)

Until October 10, Early Bird Price: $895.00 From October 11 to November 18, Regular Price: $1,095.00

Register for 10 attendees   Price: $4,922.00  $8,950.00 You Save: $4,028.00 (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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901324SEMINAR?findcpd-November-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

 

 

 

126227| Multiple Locations| HIPAA Compliance for Small Healthcare Providers|

 

 

 

Overview:

 

Being in compliance with HIPAA involves not only ensuring that you provide the appropriate patient rights and controls on your uses and disclosures of Protected Health Information; but that you also have the proper policies and procedures in place. If audited or the subject of a compliance review, you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program.

If your small healthcare practice needs to understand how to put a HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive Two-day training course.

 

Why you should attend:

 

This seminar is specially designed for small healthcare providers that struggle with meeting HIPAA compliance requirements. Regardless of the size of a practice or the number of patients, the focus of this seminar is on making sure that organizations are meeting all of the HIPAA, HITECH, and Omnibus Rules. Organizations need to fully understand the requirements of a compliance program and how to implement one.

Attendees will leave the course clearly understanding all of the requirements for a comprehensive HIPAA compliance program and what steps need to be taken to mitigate risk. The seminar will include practical exercise to assist in knowing how to develop, review, and amend HIPAA policy and procedure. After completing this course, a Healthcare Covered Entity will have a clear roadmap for what needs to be place when it comes to all of the HIPAA regulations.

 

Areas Covered in the Session:

 

  • Why was HIPAA created?
  • What are HITECH and the Omnibus Rule?
  • Who Must Comply with HIPAA Requirements?
  • What are the HIPAA Security and Privacy Rules?
  • What is a HIPAA Compliance Program?
  • What is a HIPAA Risk Management Plan?
  • What is meant by "Required" and "Addressable" Implementation Specifications?
  • What are Administrative, Technical, and Physical Safeguards Requirements?
  • Understanding the Business Associate Relationship
  • HIPAA policy and procedure practical exercise
  • What is a HIPAA Risk Assessment?
  • Risk Assessment practical exercise
  • What are HIPAA training requirements?
  • What is a HIPAA data breach and what happens if it occurs?
  • What are the penalties and fines for non-compliance and how to avoid them?
  • HIPAA & Social Media
  • Creating a Culture of Compliance
  • 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
  • Any Business Associates that accesses protected health information
  • IT Companies that support Medical/Dental practices or other healthcare organizations

 

Agenda:

 

 

Day 1 Schedule

 

Lecture 1:

What are HIPAA, HITECH & the Omnibus Rule?
HIPAA Requirements for Small Practices

Lecture 2:

Privacy Rule Requirements 
Authorized and Permitted Disclosures
Marketing in a HIPAA compliant world

Lecture 3:

Security Rule Requirements
Administrative, Technical, and Physical Safeguards
Implementation Specifications
Business Associate Agreements Managing Business Associates How to Conduct a HIPAA Risk Assessment

Lecture 4:

Risk Assessment Practical Exercise

 

Day 2 Schedule 

Lecture 1:

Review of Risk Assessment Practical Exercise
Remediation and Required Follow Up

Lecture 2:

What Policies and Procedures Must be Covered
HIPAA Risk Management Plans
Developing, Reviewing and Amending Policy and Procedure

Lecture 3:

Policy and Procedure - Practical Exercise

Lecture 4:

Review Policy and Procedure Practical Exercise
HIPAA Enforcement Trends - Concerns for Small Providers
HIPAA and Social Media
Creating a Culture of Compliance
Summary & Closing Remarks Q&A 

 

 

Speaker

Jay Hodes

President and Founder, Colington Security Consulting, LLC

 

Jay Hodes is a leading expert in HIPAA compliance and President of Colington Consulting. His company 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 many professional healthcare organizations. He has published over 35 educational articles regarding HIPAA compliance, been featured in Part B News articles, the Report on Patient Privacy, provided a guest post in the Electronic Health Reporter, and provided advice on HIPAA compliance to Renal & Urology News and the Virtru.com blog.

Mr. Hodes is a member of member of the American Institute of Healthcare Compliance, Healthcare Information and Management Systems Society, American Society for Industrial Security, Metro Collaborative, the Practice Management Association of Northern Virginia, the Health Technology Forum: DC, Association of Elderservice Professionals (VA) and the Loudoun Seniors Interest Network.

Mr. Hodes is certified by the New Jersey Board of Dentistry and the Maryland State Board of Dental Examiners to provide continuing education classes in HIPAA compliance. In his free time, Mr. Hodes is a volunteer for Lab Rescue of the Labrador Retriever Club of the Potomac and the non-profit organization, Outer Banks Sporting Events.

               

 

 

Location: Boston, MADate:  November 16th & 17th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  Embassy Suites Boston Logan Airport   207 Porter St, Boston, MA 02128, USA

 

Price:

 

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

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

Register now and save $200. (Early Bird)

Until September 30, Early Bird Price: $1,295.00 From October 01 to November 14, Regular Price: $1,495.00

 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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901282SEMINAR?findcpd-November-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

 

 

 

126228| Multiple Locations| HIPAA Compliance for Small Healthcare Providers|

 

 

 

Overview:

 

Being in compliance with HIPAA involves not only ensuring that you provide the appropriate patient rights and controls on your uses and disclosures of Protected Health Information; but that you also have the proper policies and procedures in place. If audited or the subject of a compliance review, you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program.

If your small healthcare practice needs to understand how to put a HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive Two-day training course.

 

Why you should attend:

 

This seminar is specially designed for small healthcare providers that struggle with meeting HIPAA compliance requirements. Regardless of the size of a practice or the number of patients, the focus of this seminar is on making sure that organizations are meeting all of the HIPAA, HITECH, and Omnibus Rules. Organizations need to fully understand the requirements of a compliance program and how to implement one.

Attendees will leave the course clearly understanding all of the requirements for a comprehensive HIPAA compliance program and what steps need to be taken to mitigate risk. The seminar will include practical exercise to assist in knowing how to develop, review, and amend HIPAA policy and procedure. After completing this course, a Healthcare Covered Entity will have a clear roadmap for what needs to be place when it comes to all of the HIPAA regulations.

 

Areas Covered in the Session:

 

  • Why was HIPAA created?
  • What are HITECH and the Omnibus Rule?
  • Who Must Comply with HIPAA Requirements?
  • What are the HIPAA Security and Privacy Rules?
  • What is a HIPAA Compliance Program?
  • What is a HIPAA Risk Management Plan?
  • What is meant by "Required" and "Addressable" Implementation Specifications?
  • What are Administrative, Technical, and Physical Safeguards Requirements?
  • Understanding the Business Associate Relationship
  • HIPAA policy and procedure practical exercise
  • What is a HIPAA Risk Assessment?
  • Risk Assessment practical exercise
  • What are HIPAA training requirements?
  • What is a HIPAA data breach and what happens if it occurs?
  • What are the penalties and fines for non-compliance and how to avoid them?
  • HIPAA & Social Media
  • Creating a Culture of Compliance
  • 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
  • Any Business Associates that accesses protected health information
  • IT Companies that support Medical/Dental practices or other healthcare organizations

 

Agenda:

 

 

Day 1 Schedule

 

Lecture 1:

What are HIPAA, HITECH & the Omnibus Rule?
HIPAA Requirements for Small Practices

Lecture 2:

Privacy Rule Requirements 
Authorized and Permitted Disclosures
Marketing in a HIPAA compliant world

Lecture 3:

Security Rule Requirements
Administrative, Technical, and Physical Safeguards
Implementation Specifications
Business Associate Agreements Managing Business Associates How to Conduct a HIPAA Risk Assessment

Lecture 4:

Risk Assessment Practical Exercise

 

Day 2 Schedule 

Lecture 1:

Review of Risk Assessment Practical Exercise
Remediation and Required Follow Up

Lecture 2:

What Policies and Procedures Must be Covered
HIPAA Risk Management Plans
Developing, Reviewing and Amending Policy and Procedure

Lecture 3:

Policy and Procedure - Practical Exercise

Lecture 4:

Review Policy and Procedure Practical Exercise
HIPAA Enforcement Trends - Concerns for Small Providers
HIPAA and Social Media
Creating a Culture of Compliance
Summary & Closing Remarks Q&A 

 

 

Speaker

Jay Hodes

President and Founder, Colington Security Consulting, LLC

 

Jay Hodes is a leading expert in HIPAA compliance and President of Colington Consulting. His company 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 many professional healthcare organizations. He has published over 35 educational articles regarding HIPAA compliance, been featured in Part B News articles, the Report on Patient Privacy, provided a guest post in the Electronic Health Reporter, and provided advice on HIPAA compliance to Renal & Urology News and the Virtru.com blog.

Mr. Hodes is a member of member of the American Institute of Healthcare Compliance, Healthcare Information and Management Systems Society, American Society for Industrial Security, Metro Collaborative, the Practice Management Association of Northern Virginia, the Health Technology Forum: DC, Association of Elderservice Professionals (VA) and the Loudoun Seniors Interest Network.

Mr. Hodes is certified by the New Jersey Board of Dentistry and the Maryland State Board of Dental Examiners to provide continuing education classes in HIPAA compliance. In his free time, Mr. Hodes is a volunteer for Lab Rescue of the Labrador Retriever Club of the Potomac and the non-profit organization, Outer Banks Sporting Events.

               

 

 

Location: Boston, MADate:  November 16th & 17th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  Embassy Suites Boston Logan Airport   207 Porter St, Boston, MA 02128, USA

 

Price:

 

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

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

Register now and save $200. (Early Bird)

Until September 30, Early Bird Price: $1,295.00 From October 01 to November 14, Regular Price: $1,495.00

 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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901282SEMINAR?findcpd-November-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

 

 

 

126225| Multiple Locations| GMP and Regulatory Expectations for Early IND Products 2017|

Course "GMP and Regulatory Expectations for Early IND Products" 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 will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.

 

Why should you attend:

 

Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have modified the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time some of the things that may appear to have changed, have not, and the pharmaceutical worker should be aware of this.

 

Who will benefit:

 

  • Directors, Managers, Supervisors, and lead workers in Regulatory Affairs, Quality Assurance and Quality Control
  • Workers who will prepare GMP documents for early phase products as well as those who will review these documents
  • Regulatory affairs workers who will need to deal with submissions covering early phase products

 

 

Agenda:

Day 1 Schedule

 

Lecture 1:

Very Early Stages

  • The need for documentation of matters that will affect downstream work.
  • The effects of ICH Q8
    • Impact on R & D activities
    • Risk analysis and design control at this stage.

Lecture 2:

GLP requirements

  • Animal studies
    • Toxicology and pharmacokinetics.
  • Estimating the Maximum Safe Starting Dose
    • A review of the guidance document.

Lecture 3:

Early Pre-IND Studies

  • Understanding exploratory Studies
    • Definitions and the IND that will be withdrawn.
  • Orphan Drugs
  • Drugs studied under the Animal Rule
    • What they are and how to conduct the studies.

Lecture 4:

Meetings and Preparing for the IND

  • Information required for the Phase 1 IND
    • The CMC requirements that will be needed.
  • Pre-IND Meetings with FDA

 

Day 2 Schedule

 

Lecture 1:

GMPs for Phase 1 IND products

  • The scope of the guidance document
  • The second guidance document covering the GMPs.

Lecture 2:

GMPs for Phase 1 continued

  • A presentation covering what GMPs are required at this stage.
  • What has been omitted from the GMPs for Phase 1.

Lecture 3:

Requirements for Phase 2 INDs

  • The full GMPs resume, but do they?
  • Phase 2 studies and the transition to full GMPs.
  • CMC requirements.

Lecture 4:

Preparing for IND Meetings

  • Phase 1 meetings
  • Pre-phase 2 meetings
  • Phase 2 meetings

 

 

Speaker

Dr. Steven Kuwahara

Founder & Principal, GXP Biotechnology, LLC

Dr. Steven Kuwahara, Ph.D. is the Founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories. Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.

 

 Location: Seoul, South KoreaDate:  November 9th & 10th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: WILL BE ANNOUNCED SOON, Seoul, South Korea

Price:

 

Price: $895.00 (Seminar Fee for One Delegate)

Register for 5 attendees   Price: $2,685.00   $4,475.00 You Save: $1,790.00 (40%)*

Register now and save $200. (Early Bird)

Until October 05, Early Bird Price: $895.00 From October 06 to November 07, Regular Price: $1,095.00

 Register for 10 attendees   Price: $4,922.00  $8,950.00 You Save: $4,028.00 (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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901318SEMINAR?findcpd-November-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

 

 

126226| Multiple Locations| GMP and Regulatory Expectations for Early IND Products 2017|

Course "GMP and Regulatory Expectations for Early IND Products" 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 will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.

 

Why should you attend:

 

Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have modified the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time some of the things that may appear to have changed, have not, and the pharmaceutical worker should be aware of this.

 

Who will benefit:

 

  • Directors, Managers, Supervisors, and lead workers in Regulatory Affairs, Quality Assurance and Quality Control
  • Workers who will prepare GMP documents for early phase products as well as those who will review these documents
  • Regulatory affairs workers who will need to deal with submissions covering early phase products

 

 

Agenda:

Day 1 Schedule

 

Lecture 1:

Very Early Stages

  • The need for documentation of matters that will affect downstream work.
  • The effects of ICH Q8
    • Impact on R & D activities
    • Risk analysis and design control at this stage.

Lecture 2:

GLP requirements

  • Animal studies
    • Toxicology and pharmacokinetics.
  • Estimating the Maximum Safe Starting Dose
    • A review of the guidance document.

Lecture 3:

Early Pre-IND Studies

  • Understanding exploratory Studies
    • Definitions and the IND that will be withdrawn.
  • Orphan Drugs
  • Drugs studied under the Animal Rule
    • What they are and how to conduct the studies.

Lecture 4:

Meetings and Preparing for the IND

  • Information required for the Phase 1 IND
    • The CMC requirements that will be needed.
  • Pre-IND Meetings with FDA

 

Day 2 Schedule

 

Lecture 1:

GMPs for Phase 1 IND products

  • The scope of the guidance document
  • The second guidance document covering the GMPs.

Lecture 2:

GMPs for Phase 1 continued

  • A presentation covering what GMPs are required at this stage.
  • What has been omitted from the GMPs for Phase 1.

Lecture 3:

Requirements for Phase 2 INDs

  • The full GMPs resume, but do they?
  • Phase 2 studies and the transition to full GMPs.
  • CMC requirements.

Lecture 4:

Preparing for IND Meetings

  • Phase 1 meetings
  • Pre-phase 2 meetings
  • Phase 2 meetings

 

 

Speaker

Dr. Steven Kuwahara

Founder & Principal, GXP Biotechnology, LLC

Dr. Steven Kuwahara, Ph.D. is the Founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories. Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.

 

 Location: Seoul, South KoreaDate:  November 9th & 10th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: WILL BE ANNOUNCED SOON, Seoul, South Korea

Price:

 

Price: $895.00 (Seminar Fee for One Delegate)

Register for 5 attendees   Price: $2,685.00   $4,475.00 You Save: $1,790.00 (40%)*

Register now and save $200. (Early Bird)

Until October 05, Early Bird Price: $895.00 From October 06 to November 07, Regular Price: $1,095.00

 Register for 10 attendees   Price: $4,922.00  $8,950.00 You Save: $4,028.00 (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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901318SEMINAR?findcpd-November-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

 

 

126223| Multiple Locations| Onsite GCP Review and Update including the all-important 'Investigators Responsibility' 2017|

Course "Onsite GCP Review and Update including the all-important 'Investigators Responsibility'" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

This seminar is designed to acquaint all Participants with the Rules and Regulations that form the background of what is know as the GCP of Clinical Research. To follow "The Good Clinical Practices" (GCP) is to follow the standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trails that provides assurance that the data and reported results are credible and accurate and, most importantly, that the safety, rights, integrity, and confidentiality of trial subjects is protected.

That all members of the team must know and practice "GCP" guarantees, that the Protocol is followed, that the Informed consent is complete, that the study conduct is according to the protocol, that Adverse Events are correctly recorded and that the Principal Investigator knows well her/his responsibilities to follow what "GCP" stands for

 

Why you should attend:

 

It is now reasonable to expect that the Sponsor's should become more discerning regarding the GCP qualifications and training of the staff of any unit conducting studies on human volunteers. Investigators, as well as all site staff, must know how to assess how well the unit is complying with the regulation and the essence of GCP to assure the safety of the volunteers as this ultimately affects the safety of the public. Following GCP is also an assurance of a clean audit.

 

Areas Covered in the Session:

 

Session 1:

  • What was the reason the ICH was formed
  • What is the essence of GCP
  • How does You QA group insure GCP
  • The PI/Investigators role in GCP
  • The Sponsors role in GCP
  • What is the end result of Dose response studies
  • Does your Unit/CPU/CRU follow the 13 GCP Principles?
  • How following the signed Protocol is GCP

Session 2:

  • Investigators key role in the Clin. Research process
  • How following GCP helps assure a clean Audit
  • What are the main Investigator responsibilities?
  • How is the investigator is responsible for the IC?
  • What is the legal language of the FDA form 1572?
  • Why is Financial Disclosure information important?

Session 3:

  • The Primacy of the study Protocol
  • The Pi responsibility in the Protocol development
  • The Sponsors Responsibility in Protocol development
  • How to be sure the protocol is safe for the subjects
  • How to be sure the protocol is scientifically valid
  • How to insure the to protocol is ethically valid

Session 4:

  • What is a Protocol "Deviation" and other terms
  • The Regulatory requirements for handling protocol deviations and violations
  • Importance of documentation of protocol deviations
  • What is the reason different IRBs define deviations and violations differently
  • What is the basis of the difference between a "Deviation" and a "Violation"

Session 5:

  • The historical background of why accurate data is essential for ensuring safety of study participants/Pt
  • The purpose of ensuring that all data is accurate, legible, contemporaneous, original and attributable
  • The regulatory requirements for care of source documents
  • What "To Do" and "Never Do" with regard to data including corrections?
  • What documents does the FDA review - always?

Session 6:

  • How to Assess and report AEs and SAEs
  • The CFR definitions of AEs, SAEs, and many more
  • How to know an Adverse Event and when to report it
  • Understanding laboratory AEs and the "Reference Range" concept
  • Common Mistakes in AE / SAE Reporting
  • Reporting of Adverse Events - when and to whom
  • how Data safety Monitoring in Protects Volunteers

Session 7:

  • The Sponsor's responsibility in quality monitoring
  • Why Monitor Clinical Studies
  • What does a Monitor look for?
  • How does a Sponsor or Site prepare for an Audit
  • What are the strategies to improve an audit outcome?
  • What does the FDA look at when Auditing/Inspecting a study?
  • What types of studies are targeted for auditing

Session 8:

  • The function of/reasons for an SOP in a CPU/CRU
  • How SOPs are set up
  • What areas of CPU management need SOPs
  • Who creates an/the SOPs
  • Who is responsible for the Unit's SOPs

 

Who will benefit:

 

This lecture series will provide invaluable assistance to industry study sponsors and those involved in Setting up the IND to follow the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (IMP) research involving human subjects. Those benefiting the most would be:

  • The Study Sponsor
  • Principal Investigators and sub investigators
  • Clinical Research Scientists (PKs, Biostatisticians, ...)
  • Safety Nurses
  • Clinical Research Associates (CRAs) and Coordinators (CRCs)
  • Recruiting staff, QA / QC auditors and staff, & Clinical Research Data managers.

 

 

Agenda:

 

Day 1 Schedule 

Lecture 1:

What is GCP and how does this concept improve data integrity and subject safety.The International Council on Harmonization leads the way

Lecture 2:

The Responsibilities of the Investigator and the relationship of the Investigator to the Sponsor and the IRB. The Regulations are quite clear in this regard. This includes the Informed Consent Process

Lecture 3:

In The Beginning: A solid Protocol; The basis of Drug Development starts with a medically sound Phase I Protocol, which defines Feasibility. Phase II and II Protocols must also be scientifically, medically, as well as ethically sound

Lecture 4:

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?

Day 2 Schedule

Lecture 5:

To conduct the Clinical Research study as if a persons life depended on it - because it does

Lecture 6:

The Importance of Proper AE Determination and Reporting: How to handle AE's not in the Investigators brochure (IB) and properly assess the relationship between the AE and the product.

Lecture 7:

The Value of the Monitoring Process to an FDA Audit: including how a site or CRO prepares for an Audit and what the Auditors are finding.

Lecture 8:

The Importance of Standard Operating Procedures (SOPs) in the operation of a FDA form 483 absent CPU/CRU

 

 

Speaker

Charles H. Pierce

 

Charles H Pierce, MD, PhD, FCP, CPI From an original Master's thesis (MSc in Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 48+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 28+ years in the medical research industry (7 years as a Principal Investigator), Charles has an experienced based knowledge of the Clinical Research part of Drug Development.

He is an APPI/APCR Certified Principal Investigator (CPI in 2003 and recertification's to 2018). He is actively involved in giving talks, Webinars, courses and workshops giving the clinical investigator and staff an understanding and appreciation of the ethics as well as the science and regulations governing clinical research with drugs or devices. The end must be knowledge and keen observation to ensure drug safety.

Charles' active management experience in the medical research industry gives him first-hand practical experience and knowledge to develop Phase I, IIa confined study Clinical Pharmacology Units (CPU's). From experience and practical know-how the special needs of these units (from the floor plans to operational SOPs) has been of added value to those considering this venture. He has work experience in Device Studies and Pharmacovigilance. The later (PV) is of special interest as Phase I through Phase III do not guarantee drug safety. Actually this vigilance must start with the very first studies in human subjects.

Charles is a Fellow and Life Member of the American Academy of Family Physicians and Emeritus fellow of the American College of Clinical Pharmacology (ACCP) of which he was a Regent 1995-2000, Chairman of the 2001 annual meeting, and the 2004 recipient of the Nathaniel Kwitt Distinguished Service Award. He is an active member of the Association of Clinical Pharmacology Units (ACPU) of which he was a trustee (2007-2011) and chaired the successful 2010 annual meeting. He is also a member of the Academy of Physicians in Clinical Research (APCR) and the 2012 Chair of the Board to trustees of the Academy of the Association of Clinical Research Professionals (ACRP).

Presently, he works part time in Urgent Care and is a 'waved' physician in The Addiction epidemic, Charles was an active squash player for 45 years, has been a committed Rotarian for 38 years, and a hobby photographer.

 

 

 Location: Baltimore, MDDate:  November 2nd & 3rd, 2017 and Time: 9:00 AM to 4:00 PM

Venue: WILL BE ANNOUNCED SOON Baltimore, MD

 

Price:

 

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

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

Register now and save $200. (Early Bird)

Until September 20, Early Bird Price: $1,295.00 From September 21 to October 31, Regular Price: $1,495.00

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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901348SEMINAR?findcpd-November-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

 

 

126224| Multiple Locations| Onsite GCP Review and Update including the all-important 'Investigators Responsibility' 2017|

Course "Onsite GCP Review and Update including the all-important 'Investigators Responsibility'" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

This seminar is designed to acquaint all Participants with the Rules and Regulations that form the background of what is know as the GCP of Clinical Research. To follow "The Good Clinical Practices" (GCP) is to follow the standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trails that provides assurance that the data and reported results are credible and accurate and, most importantly, that the safety, rights, integrity, and confidentiality of trial subjects is protected.

That all members of the team must know and practice "GCP" guarantees, that the Protocol is followed, that the Informed consent is complete, that the study conduct is according to the protocol, that Adverse Events are correctly recorded and that the Principal Investigator knows well her/his responsibilities to follow what "GCP" stands for

 

Why you should attend:

 

It is now reasonable to expect that the Sponsor's should become more discerning regarding the GCP qualifications and training of the staff of any unit conducting studies on human volunteers. Investigators, as well as all site staff, must know how to assess how well the unit is complying with the regulation and the essence of GCP to assure the safety of the volunteers as this ultimately affects the safety of the public. Following GCP is also an assurance of a clean audit.

 

Areas Covered in the Session:

 

Session 1:

  • What was the reason the ICH was formed
  • What is the essence of GCP
  • How does You QA group insure GCP
  • The PI/Investigators role in GCP
  • The Sponsors role in GCP
  • What is the end result of Dose response studies
  • Does your Unit/CPU/CRU follow the 13 GCP Principles?
  • How following the signed Protocol is GCP

Session 2:

  • Investigators key role in the Clin. Research process
  • How following GCP helps assure a clean Audit
  • What are the main Investigator responsibilities?
  • How is the investigator is responsible for the IC?
  • What is the legal language of the FDA form 1572?
  • Why is Financial Disclosure information important?

Session 3:

  • The Primacy of the study Protocol
  • The Pi responsibility in the Protocol development
  • The Sponsors Responsibility in Protocol development
  • How to be sure the protocol is safe for the subjects
  • How to be sure the protocol is scientifically valid
  • How to insure the to protocol is ethically valid

Session 4:

  • What is a Protocol "Deviation" and other terms
  • The Regulatory requirements for handling protocol deviations and violations
  • Importance of documentation of protocol deviations
  • What is the reason different IRBs define deviations and violations differently
  • What is the basis of the difference between a "Deviation" and a "Violation"

Session 5:

  • The historical background of why accurate data is essential for ensuring safety of study participants/Pt
  • The purpose of ensuring that all data is accurate, legible, contemporaneous, original and attributable
  • The regulatory requirements for care of source documents
  • What "To Do" and "Never Do" with regard to data including corrections?
  • What documents does the FDA review - always?

Session 6:

  • How to Assess and report AEs and SAEs
  • The CFR definitions of AEs, SAEs, and many more
  • How to know an Adverse Event and when to report it
  • Understanding laboratory AEs and the "Reference Range" concept
  • Common Mistakes in AE / SAE Reporting
  • Reporting of Adverse Events - when and to whom
  • how Data safety Monitoring in Protects Volunteers

Session 7:

  • The Sponsor's responsibility in quality monitoring
  • Why Monitor Clinical Studies
  • What does a Monitor look for?
  • How does a Sponsor or Site prepare for an Audit
  • What are the strategies to improve an audit outcome?
  • What does the FDA look at when Auditing/Inspecting a study?
  • What types of studies are targeted for auditing

Session 8:

  • The function of/reasons for an SOP in a CPU/CRU
  • How SOPs are set up
  • What areas of CPU management need SOPs
  • Who creates an/the SOPs
  • Who is responsible for the Unit's SOPs

 

Who will benefit:

 

This lecture series will provide invaluable assistance to industry study sponsors and those involved in Setting up the IND to follow the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (IMP) research involving human subjects. Those benefiting the most would be:

  • The Study Sponsor
  • Principal Investigators and sub investigators
  • Clinical Research Scientists (PKs, Biostatisticians, ...)
  • Safety Nurses
  • Clinical Research Associates (CRAs) and Coordinators (CRCs)
  • Recruiting staff, QA / QC auditors and staff, & Clinical Research Data managers.

 

 

Agenda:

 

Day 1 Schedule 

Lecture 1:

What is GCP and how does this concept improve data integrity and subject safety.The International Council on Harmonization leads the way

Lecture 2:

The Responsibilities of the Investigator and the relationship of the Investigator to the Sponsor and the IRB. The Regulations are quite clear in this regard. This includes the Informed Consent Process

Lecture 3:

In The Beginning: A solid Protocol; The basis of Drug Development starts with a medically sound Phase I Protocol, which defines Feasibility. Phase II and II Protocols must also be scientifically, medically, as well as ethically sound

Lecture 4:

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?

Day 2 Schedule

Lecture 5:

To conduct the Clinical Research study as if a persons life depended on it - because it does

Lecture 6:

The Importance of Proper AE Determination and Reporting: How to handle AE's not in the Investigators brochure (IB) and properly assess the relationship between the AE and the product.

Lecture 7:

The Value of the Monitoring Process to an FDA Audit: including how a site or CRO prepares for an Audit and what the Auditors are finding.

Lecture 8:

The Importance of Standard Operating Procedures (SOPs) in the operation of a FDA form 483 absent CPU/CRU

 

 

Speaker

Charles H. Pierce

 

Charles H Pierce, MD, PhD, FCP, CPI From an original Master's thesis (MSc in Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 48+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 28+ years in the medical research industry (7 years as a Principal Investigator), Charles has an experienced based knowledge of the Clinical Research part of Drug Development.

He is an APPI/APCR Certified Principal Investigator (CPI in 2003 and recertification's to 2018). He is actively involved in giving talks, Webinars, courses and workshops giving the clinical investigator and staff an understanding and appreciation of the ethics as well as the science and regulations governing clinical research with drugs or devices. The end must be knowledge and keen observation to ensure drug safety.

Charles' active management experience in the medical research industry gives him first-hand practical experience and knowledge to develop Phase I, IIa confined study Clinical Pharmacology Units (CPU's). From experience and practical know-how the special needs of these units (from the floor plans to operational SOPs) has been of added value to those considering this venture. He has work experience in Device Studies and Pharmacovigilance. The later (PV) is of special interest as Phase I through Phase III do not guarantee drug safety. Actually this vigilance must start with the very first studies in human subjects.

Charles is a Fellow and Life Member of the American Academy of Family Physicians and Emeritus fellow of the American College of Clinical Pharmacology (ACCP) of which he was a Regent 1995-2000, Chairman of the 2001 annual meeting, and the 2004 recipient of the Nathaniel Kwitt Distinguished Service Award. He is an active member of the Association of Clinical Pharmacology Units (ACPU) of which he was a trustee (2007-2011) and chaired the successful 2010 annual meeting. He is also a member of the Academy of Physicians in Clinical Research (APCR) and the 2012 Chair of the Board to trustees of the Academy of the Association of Clinical Research Professionals (ACRP).

Presently, he works part time in Urgent Care and is a 'waved' physician in The Addiction epidemic, Charles was an active squash player for 45 years, has been a committed Rotarian for 38 years, and a hobby photographer.

 

 

 Location: Baltimore, MDDate:  November 2nd & 3rd, 2017 and Time: 9:00 AM to 4:00 PM

Venue: WILL BE ANNOUNCED SOON Baltimore, MD

 

Price:

 

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

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

Register now and save $200. (Early Bird)

Until September 20, Early Bird Price: $1,295.00 From September 21 to October 31, Regular Price: $1,495.00

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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901348SEMINAR?findcpd-November-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

 

 

126221| Multiple Locations| Complete 1099, TIN Matching, B-Notice, FATCA 2017|

Course "Onsite GCP Review and Update including the all-important 'Investigators Responsibility'" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

This seminar is designed to acquaint all Participants with the Rules and Regulations that form the background of what is know as the GCP of Clinical Research. To follow "The Good Clinical Practices" (GCP) is to follow the standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trails that provides assurance that the data and reported results are credible and accurate and, most importantly, that the safety, rights, integrity, and confidentiality of trial subjects is protected.

That all members of the team must know and practice "GCP" guarantees, that the Protocol is followed, that the Informed consent is complete, that the study conduct is according to the protocol, that Adverse Events are correctly recorded and that the Principal Investigator knows well her/his responsibilities to follow what "GCP" stands for

 

Why you should attend:

 

It is now reasonable to expect that the Sponsor's should become more discerning regarding the GCP qualifications and training of the staff of any unit conducting studies on human volunteers. Investigators, as well as all site staff, must know how to assess how well the unit is complying with the regulation and the essence of GCP to assure the safety of the volunteers as this ultimately affects the safety of the public. Following GCP is also an assurance of a clean audit.

 

Areas Covered in the Session:

 

Session 1:

  • What was the reason the ICH was formed
  • What is the essence of GCP
  • How does You QA group insure GCP
  • The PI/Investigators role in GCP
  • The Sponsors role in GCP
  • What is the end result of Dose response studies
  • Does your Unit/CPU/CRU follow the 13 GCP Principles?
  • How following the signed Protocol is GCP

Session 2:

  • Investigators key role in the Clin. Research process
  • How following GCP helps assure a clean Audit
  • What are the main Investigator responsibilities?
  • How is the investigator is responsible for the IC?
  • What is the legal language of the FDA form 1572?
  • Why is Financial Disclosure information important?

Session 3:

  • The Primacy of the study Protocol
  • The Pi responsibility in the Protocol development
  • The Sponsors Responsibility in Protocol development
  • How to be sure the protocol is safe for the subjects
  • How to be sure the protocol is scientifically valid
  • How to insure the to protocol is ethically valid

Session 4:

  • What is a Protocol "Deviation" and other terms
  • The Regulatory requirements for handling protocol deviations and violations
  • Importance of documentation of protocol deviations
  • What is the reason different IRBs define deviations and violations differently
  • What is the basis of the difference between a "Deviation" and a "Violation"

Session 5:

  • The historical background of why accurate data is essential for ensuring safety of study participants/Pt
  • The purpose of ensuring that all data is accurate, legible, contemporaneous, original and attributable
  • The regulatory requirements for care of source documents
  • What "To Do" and "Never Do" with regard to data including corrections?
  • What documents does the FDA review - always?

Session 6:

  • How to Assess and report AEs and SAEs
  • The CFR definitions of AEs, SAEs, and many more
  • How to know an Adverse Event and when to report it
  • Understanding laboratory AEs and the "Reference Range" concept
  • Common Mistakes in AE / SAE Reporting
  • Reporting of Adverse Events - when and to whom
  • how Data safety Monitoring in Protects Volunteers

Session 7:

  • The Sponsor's responsibility in quality monitoring
  • Why Monitor Clinical Studies
  • What does a Monitor look for?
  • How does a Sponsor or Site prepare for an Audit
  • What are the strategies to improve an audit outcome?
  • What does the FDA look at when Auditing/Inspecting a study?
  • What types of studies are targeted for auditing

Session 8:

  • The function of/reasons for an SOP in a CPU/CRU
  • How SOPs are set up
  • What areas of CPU management need SOPs
  • Who creates an/the SOPs
  • Who is responsible for the Unit's SOPs

 

Who will benefit:

 

This lecture series will provide invaluable assistance to industry study sponsors and those involved in Setting up the IND to follow the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (IMP) research involving human subjects. Those benefiting the most would be:

  • The Study Sponsor
  • Principal Investigators and sub investigators
  • Clinical Research Scientists (PKs, Biostatisticians, ...)
  • Safety Nurses
  • Clinical Research Associates (CRAs) and Coordinators (CRCs)
  • Recruiting staff, QA / QC auditors and staff, & Clinical Research Data managers.

 

 

Agenda:

 

Day 1 Schedule 

Lecture 1:

What is GCP and how does this concept improve data integrity and subject safety.The International Council on Harmonization leads the way

Lecture 2:

The Responsibilities of the Investigator and the relationship of the Investigator to the Sponsor and the IRB. The Regulations are quite clear in this regard. This includes the Informed Consent Process

Lecture 3:

In The Beginning: A solid Protocol; The basis of Drug Development starts with a medically sound Phase I Protocol, which defines Feasibility. Phase II and II Protocols must also be scientifically, medically, as well as ethically sound

Lecture 4:

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?

Day 2 Schedule

Lecture 5:

To conduct the Clinical Research study as if a persons life depended on it - because it does

Lecture 6:

The Importance of Proper AE Determination and Reporting: How to handle AE's not in the Investigators brochure (IB) and properly assess the relationship between the AE and the product.

Lecture 7:

The Value of the Monitoring Process to an FDA Audit: including how a site or CRO prepares for an Audit and what the Auditors are finding.

Lecture 8:

The Importance of Standard Operating Procedures (SOPs) in the operation of a FDA form 483 absent CPU/CRU

 

 

Speaker

Charles H. Pierce

 

Charles H Pierce, MD, PhD, FCP, CPI From an original Master's thesis (MSc in Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 48+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 28+ years in the medical research industry (7 years as a Principal Investigator), Charles has an experienced based knowledge of the Clinical Research part of Drug Development.

He is an APPI/APCR Certified Principal Investigator (CPI in 2003 and recertification's to 2018). He is actively involved in giving talks, Webinars, courses and workshops giving the clinical investigator and staff an understanding and appreciation of the ethics as well as the science and regulations governing clinical research with drugs or devices. The end must be knowledge and keen observation to ensure drug safety.

Charles' active management experience in the medical research industry gives him first-hand practical experience and knowledge to develop Phase I, IIa confined study Clinical Pharmacology Units (CPU's). From experience and practical know-how the special needs of these units (from the floor plans to operational SOPs) has been of added value to those considering this venture. He has work experience in Device Studies and Pharmacovigilance. The later (PV) is of special interest as Phase I through Phase III do not guarantee drug safety. Actually this vigilance must start with the very first studies in human subjects.

Charles is a Fellow and Life Member of the American Academy of Family Physicians and Emeritus fellow of the American College of Clinical Pharmacology (ACCP) of which he was a Regent 1995-2000, Chairman of the 2001 annual meeting, and the 2004 recipient of the Nathaniel Kwitt Distinguished Service Award. He is an active member of the Association of Clinical Pharmacology Units (ACPU) of which he was a trustee (2007-2011) and chaired the successful 2010 annual meeting. He is also a member of the Academy of Physicians in Clinical Research (APCR) and the 2012 Chair of the Board to trustees of the Academy of the Association of Clinical Research Professionals (ACRP).

Presently, he works part time in Urgent Care and is a 'waved' physician in The Addiction epidemic, Charles was an active squash player for 45 years, has been a committed Rotarian for 38 years, and a hobby photographer.

 

 

 Location: Baltimore, MDDate:  November 2nd & 3rd, 2017 and Time: 9:00 AM to 4:00 PM

Venue: WILL BE ANNOUNCED SOON Baltimore, MD

 

Price:

 

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

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

Register now and save $200. (Early Bird)

Until September 20, Early Bird Price: $1,295.00 From September 21 to October 31, Regular Price: $1,495.00

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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901330SEMINAR?findcpd-November-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

 

 

126222| Multiple Locations| Complete 1099, TIN Matching, B-Notice, FATCA 2017|

Course "Onsite GCP Review and Update including the all-important 'Investigators Responsibility'" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

This seminar is designed to acquaint all Participants with the Rules and Regulations that form the background of what is know as the GCP of Clinical Research. To follow "The Good Clinical Practices" (GCP) is to follow the standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trails that provides assurance that the data and reported results are credible and accurate and, most importantly, that the safety, rights, integrity, and confidentiality of trial subjects is protected.

That all members of the team must know and practice "GCP" guarantees, that the Protocol is followed, that the Informed consent is complete, that the study conduct is according to the protocol, that Adverse Events are correctly recorded and that the Principal Investigator knows well her/his responsibilities to follow what "GCP" stands for

 

Why you should attend:

 

It is now reasonable to expect that the Sponsor's should become more discerning regarding the GCP qualifications and training of the staff of any unit conducting studies on human volunteers. Investigators, as well as all site staff, must know how to assess how well the unit is complying with the regulation and the essence of GCP to assure the safety of the volunteers as this ultimately affects the safety of the public. Following GCP is also an assurance of a clean audit.

 

Areas Covered in the Session:

 

Session 1:

  • What was the reason the ICH was formed
  • What is the essence of GCP
  • How does You QA group insure GCP
  • The PI/Investigators role in GCP
  • The Sponsors role in GCP
  • What is the end result of Dose response studies
  • Does your Unit/CPU/CRU follow the 13 GCP Principles?
  • How following the signed Protocol is GCP

Session 2:

  • Investigators key role in the Clin. Research process
  • How following GCP helps assure a clean Audit
  • What are the main Investigator responsibilities?
  • How is the investigator is responsible for the IC?
  • What is the legal language of the FDA form 1572?
  • Why is Financial Disclosure information important?

Session 3:

  • The Primacy of the study Protocol
  • The Pi responsibility in the Protocol development
  • The Sponsors Responsibility in Protocol development
  • How to be sure the protocol is safe for the subjects
  • How to be sure the protocol is scientifically valid
  • How to insure the to protocol is ethically valid

Session 4:

  • What is a Protocol "Deviation" and other terms
  • The Regulatory requirements for handling protocol deviations and violations
  • Importance of documentation of protocol deviations
  • What is the reason different IRBs define deviations and violations differently
  • What is the basis of the difference between a "Deviation" and a "Violation"

Session 5:

  • The historical background of why accurate data is essential for ensuring safety of study participants/Pt
  • The purpose of ensuring that all data is accurate, legible, contemporaneous, original and attributable
  • The regulatory requirements for care of source documents
  • What "To Do" and "Never Do" with regard to data including corrections?
  • What documents does the FDA review - always?

Session 6:

  • How to Assess and report AEs and SAEs
  • The CFR definitions of AEs, SAEs, and many more
  • How to know an Adverse Event and when to report it
  • Understanding laboratory AEs and the "Reference Range" concept
  • Common Mistakes in AE / SAE Reporting
  • Reporting of Adverse Events - when and to whom
  • how Data safety Monitoring in Protects Volunteers

Session 7:

  • The Sponsor's responsibility in quality monitoring
  • Why Monitor Clinical Studies
  • What does a Monitor look for?
  • How does a Sponsor or Site prepare for an Audit
  • What are the strategies to improve an audit outcome?
  • What does the FDA look at when Auditing/Inspecting a study?
  • What types of studies are targeted for auditing

Session 8:

  • The function of/reasons for an SOP in a CPU/CRU
  • How SOPs are set up
  • What areas of CPU management need SOPs
  • Who creates an/the SOPs
  • Who is responsible for the Unit's SOPs

 

Who will benefit:

 

This lecture series will provide invaluable assistance to industry study sponsors and those involved in Setting up the IND to follow the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (IMP) research involving human subjects. Those benefiting the most would be:

  • The Study Sponsor
  • Principal Investigators and sub investigators
  • Clinical Research Scientists (PKs, Biostatisticians, ...)
  • Safety Nurses
  • Clinical Research Associates (CRAs) and Coordinators (CRCs)
  • Recruiting staff, QA / QC auditors and staff, & Clinical Research Data managers.

 

 

Agenda:

 

Day 1 Schedule 

Lecture 1:

What is GCP and how does this concept improve data integrity and subject safety.The International Council on Harmonization leads the way

Lecture 2:

The Responsibilities of the Investigator and the relationship of the Investigator to the Sponsor and the IRB. The Regulations are quite clear in this regard. This includes the Informed Consent Process

Lecture 3:

In The Beginning: A solid Protocol; The basis of Drug Development starts with a medically sound Phase I Protocol, which defines Feasibility. Phase II and II Protocols must also be scientifically, medically, as well as ethically sound

Lecture 4:

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?

Day 2 Schedule

Lecture 5:

To conduct the Clinical Research study as if a persons life depended on it - because it does

Lecture 6:

The Importance of Proper AE Determination and Reporting: How to handle AE's not in the Investigators brochure (IB) and properly assess the relationship between the AE and the product.

Lecture 7:

The Value of the Monitoring Process to an FDA Audit: including how a site or CRO prepares for an Audit and what the Auditors are finding.

Lecture 8:

The Importance of Standard Operating Procedures (SOPs) in the operation of a FDA form 483 absent CPU/CRU

 

 

Speaker

Charles H. Pierce

 

Charles H Pierce, MD, PhD, FCP, CPI From an original Master's thesis (MSc in Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 48+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 28+ years in the medical research industry (7 years as a Principal Investigator), Charles has an experienced based knowledge of the Clinical Research part of Drug Development.

He is an APPI/APCR Certified Principal Investigator (CPI in 2003 and recertification's to 2018). He is actively involved in giving talks, Webinars, courses and workshops giving the clinical investigator and staff an understanding and appreciation of the ethics as well as the science and regulations governing clinical research with drugs or devices. The end must be knowledge and keen observation to ensure drug safety.

Charles' active management experience in the medical research industry gives him first-hand practical experience and knowledge to develop Phase I, IIa confined study Clinical Pharmacology Units (CPU's). From experience and practical know-how the special needs of these units (from the floor plans to operational SOPs) has been of added value to those considering this venture. He has work experience in Device Studies and Pharmacovigilance. The later (PV) is of special interest as Phase I through Phase III do not guarantee drug safety. Actually this vigilance must start with the very first studies in human subjects.

Charles is a Fellow and Life Member of the American Academy of Family Physicians and Emeritus fellow of the American College of Clinical Pharmacology (ACCP) of which he was a Regent 1995-2000, Chairman of the 2001 annual meeting, and the 2004 recipient of the Nathaniel Kwitt Distinguished Service Award. He is an active member of the Association of Clinical Pharmacology Units (ACPU) of which he was a trustee (2007-2011) and chaired the successful 2010 annual meeting. He is also a member of the Academy of Physicians in Clinical Research (APCR) and the 2012 Chair of the Board to trustees of the Academy of the Association of Clinical Research Professionals (ACRP).

Presently, he works part time in Urgent Care and is a 'waved' physician in The Addiction epidemic, Charles was an active squash player for 45 years, has been a committed Rotarian for 38 years, and a hobby photographer.

 

 

 Location: Baltimore, MDDate:  November 2nd & 3rd, 2017 and Time: 9:00 AM to 4:00 PM

Venue: WILL BE ANNOUNCED SOON Baltimore, MD

 

Price:

 

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

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

Register now and save $200. (Early Bird)

Until September 20, Early Bird Price: $1,295.00 From September 21 to October 31, Regular Price: $1,495.00

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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901330SEMINAR?findcpd-November-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

 

 

126219| Multiple Locations| HIPAA Privacy and Security - Time to get Serious 2017|

Overview:

 

This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more.

It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond.

There are an enormous amount of issues and risks for covered entities and business associates these days.

I will speak on specific experiences from over 17 years of experience 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.

More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices.

 

Why you should attend:

 

Omnibus has changed the HIPAA landscape for good!

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

Protect your practice or business!

These days trial attorneys pose a higher risk than the Federal government!

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

What factors might spurn a lawsuit or a HIPAA audit? ...Are you doing these things?

Why are the Feds enforcing after all these years?

We will be discussing 2017 changes taking place in Washington with the Health and Human Services in regards to the enforcement of the HIPAA laws already on the books as well as some detailed discussions on the Phase 2 audit process as well as some current events regarding HIPAA cases (both in courtrooms and from live audits)

 

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 Privacy Rule vs HIPAA Security Rule

Lecture 2: HITECH Act

Lecture 3: HIPAA -History

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: BYOD

Lecture 2: Texting and Emailing

Lecture 3: Choosing a HIPAA Consultant

Lecture 4: Choosing an IT Group

Lecture 5: Disaster Recovery Concerns (Electronic)

Lecture 6: Physical Setup

Lecture 7: Overseas Outsourcing

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: Phoenix, AZ Date:  November 2nd & 3rd, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Courtyard Tempe Downtown   601 South Ash Avenue Tempe Arizona 85281

 

Price:

 

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

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

Register now and save $200. (Early Bird)

Until September 20, Early Bird Price: $1,295.00 From September 21 to October 31, Regular Price: $1,495.00

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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901044SEMINAR?findcpd-November-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

 

 

126220| Multiple Locations| HIPAA Privacy and Security - Time to get Serious 2017|

Overview:

 

This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more.

It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond.

There are an enormous amount of issues and risks for covered entities and business associates these days.

I will speak on specific experiences from over 17 years of experience 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.

More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices.

 

Why you should attend:

 

Omnibus has changed the HIPAA landscape for good!

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

Protect your practice or business!

These days trial attorneys pose a higher risk than the Federal government!

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

What factors might spurn a lawsuit or a HIPAA audit? ...Are you doing these things?

Why are the Feds enforcing after all these years?

We will be discussing 2017 changes taking place in Washington with the Health and Human Services in regards to the enforcement of the HIPAA laws already on the books as well as some detailed discussions on the Phase 2 audit process as well as some current events regarding HIPAA cases (both in courtrooms and from live audits)

 

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 Privacy Rule vs HIPAA Security Rule

Lecture 2: HITECH Act

Lecture 3: HIPAA -History

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: BYOD

Lecture 2: Texting and Emailing

Lecture 3: Choosing a HIPAA Consultant

Lecture 4: Choosing an IT Group

Lecture 5: Disaster Recovery Concerns (Electronic)

Lecture 6: Physical Setup

Lecture 7: Overseas Outsourcing

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: Phoenix, AZ Date:  November 2nd & 3rd, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Courtyard Tempe Downtown   601 South Ash Avenue Tempe Arizona 85281

 

Price:

 

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

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

Register now and save $200. (Early Bird)

Until September 20, Early Bird Price: $1,295.00 From September 21 to October 31, Regular Price: $1,495.00

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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901044SEMINAR?findcpd-November-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

 

 

126217| Multiple Locations| The EU Clinical Trial Regulation + EU Filings & Registrations 2017|

 

Course "The EU Clinical Trial Regulation + EU Filings & Registrations" 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 covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive and the impending changes coming to the EU through the EU Clinical Trial Regulation (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the new regulatory framework, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. Additionally, the seminar will cover the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing].

This course covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States [and EEA], as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.

 

Learning Objectives / Key Topics:

 

Attendees will leave the Course clearly understanding the requirements under the current Directive. In addition, this Course has been updated to provide participants with competitive insight into:

  • How the EU and individual countries within Europe interact
  • Which registration procedure to use
  • How regulations effect product development strategies
  • Pricing issues - Coordinated filing vs. Individual filing
  • Understanding the concerns/issues of European Regulatory Personnel
  • How to negotiate with the regulators
  • Information necessary for effective submissions
  • Strategies for streamlining the registration application process for faster approval
  • The advantages and disadvantages of various registration procedures
  • How to efficiently initiate trials.....first patient, first visit
  • How to link the strategy of Country Selection to an ultimate EU Licensing Plan
  • Efficiently implementing studies via project teams and CROs at the National and multi-state level
  • How to stay compliant.....What can make the difference in your data passing Regulatory scrutiny
  • Related area-GCP and PV-reporting updates
  • EUCTD and EUCTR vs. FDA IND Regulations
  • Impending Changes of the EU Clinical Trial Regulation and timing for Implementation

 

Agenda:

 

Day 1 Schedule

 

EU Clinical Trial Directive / New EU CT Regulation

 

Lecture 1:

Overview of the EU and EU Regulatory Structure

Lecture 2:

Overview of the EU Clinical Trial Directive, the 2007 Pediatric Legislation

Lecture 3:

Impending Changes of the EU Clinical Trial Regulation

Lecture 4:

Clinical Trials in the EU

  • Phases of a clinical trial
  • Start-Up and Application Processes
  • Ethics Committee and Competent Authority Review Process
  • Trial Protocol and Management
  • GCP and GMP Compliance
  • Labeling Requirements
  • Fees

Lecture 5:

End of a Clinical Trial

Lecture 6:

How Changes of the new Clinical Trial Regulation will affect Sponsors

 

Day 2 Schedule

 

European Filing & Registration Procedures

 

Lecture 1:

EU Agency Regulatory Structure

Lecture 2:

Registration Options

Lecture 3:

Company Strategy- Linking Clinical Trials & Marketing Authorization Applications

Lecture 4:

Balancing Strategy and Long Term Regulatory Cost & Maintenance

Lecture 5:

Registration Procedures

  • Member State Procedures
  • Mutual Recognition Procedure
  • Centralized Procedure

Lecture 6:

Abridged Applications

  • Similar Products & Devices
  • Request for Extensions
  • Use of Expert Reports

Lecture 7:

Generics, Orphan Drugs, Biologics and Combination Products

Lecture 8:

Variations

  • Changes Concerning Manufacturing Aspects (Product & Process)
  • Labeling & Packaging Leaflet Requirements
  • EU Commission Regulations

Lecture 9:

Decision Making Process

  • Scope
  • Check-in Procedure
  • Internal Commission
  • Consultation
  • Industry's Ability to Impact?- Involvement & Timing
  • Standing Committee Participation
  • Favorable Standing Committee Opinion
  • Non-Favorable Opinion ?- Process & Timing

Lecture 10:

Review of Regulatory Authorities

  • International, Regional, and Local laws applicable for each European Union Nation

Lecture 11:

Member State Analysis of Applicable Regulations At All Levels With Practical Examples of How the Regulations Are Applied

  • Legislative Process
  • Objectives of the Rules Governing Medicinal Procedures
  • Regulatory Framework
  • New Products, Requirements, & Procedures

Lecture 12:

Political Implications of The Regulations

  • Compare/Contrast EMA and the FDA procedures

Lecture 13:

How and When to Influence the Regulatory Process

  • Effective Monitoring Activity
  • Association vs. Individual Company Involvement & Intervention
  • The Regulatory Negotiation Process
  • Effective Approaches
  • The Do's and Don'ts of Regulatory Involvement

Lecture 14:

How to Use Regulations / Regulatory Contacts to Your Advantage

  • Check-in Procedure
  • Internal Commission Interactions
  • Procedures within each regulatory office, contacts, etc.
    • Product Development Strategy
  • Business Impact Within and Outside the EU
  • Professionalism in Regulatory Lobbying

Lecture 15:

Maintaining Your License: Renewals

Lecture 16:

Helpful Websites

Lecture 17:

Glossary of Terms

 

Speaker

Robert Russell

President, RJR Consulting, Inc. 

For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.

 

Location: Zurich, Switzerland Date:  November 2nd & 3rd, 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:

 

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

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

Register now and save $200. (Early Bird)

Until September 15, Early Bird Price: $1,695.00 From September 16 to October 31, Regular Price: $1,895.00

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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901354SEMINAR?findcpd-November-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

 

126218| Multiple Locations| The EU Clinical Trial Regulation + EU Filings & Registrations 2017|

 

Course "The EU Clinical Trial Regulation + EU Filings & Registrations" 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 covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive and the impending changes coming to the EU through the EU Clinical Trial Regulation (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the new regulatory framework, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. Additionally, the seminar will cover the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing].

This course covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States [and EEA], as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.

 

Learning Objectives / Key Topics:

 

Attendees will leave the Course clearly understanding the requirements under the current Directive. In addition, this Course has been updated to provide participants with competitive insight into:

  • How the EU and individual countries within Europe interact
  • Which registration procedure to use
  • How regulations effect product development strategies
  • Pricing issues - Coordinated filing vs. Individual filing
  • Understanding the concerns/issues of European Regulatory Personnel
  • How to negotiate with the regulators
  • Information necessary for effective submissions
  • Strategies for streamlining the registration application process for faster approval
  • The advantages and disadvantages of various registration procedures
  • How to efficiently initiate trials.....first patient, first visit
  • How to link the strategy of Country Selection to an ultimate EU Licensing Plan
  • Efficiently implementing studies via project teams and CROs at the National and multi-state level
  • How to stay compliant.....What can make the difference in your data passing Regulatory scrutiny
  • Related area-GCP and PV-reporting updates
  • EUCTD and EUCTR vs. FDA IND Regulations
  • Impending Changes of the EU Clinical Trial Regulation and timing for Implementation

 

Agenda:

 

Day 1 Schedule

 

EU Clinical Trial Directive / New EU CT Regulation

 

Lecture 1:

Overview of the EU and EU Regulatory Structure

Lecture 2:

Overview of the EU Clinical Trial Directive, the 2007 Pediatric Legislation

Lecture 3:

Impending Changes of the EU Clinical Trial Regulation

Lecture 4:

Clinical Trials in the EU

  • Phases of a clinical trial
  • Start-Up and Application Processes
  • Ethics Committee and Competent Authority Review Process
  • Trial Protocol and Management
  • GCP and GMP Compliance
  • Labeling Requirements
  • Fees

Lecture 5:

End of a Clinical Trial

Lecture 6:

How Changes of the new Clinical Trial Regulation will affect Sponsors

 

Day 2 Schedule

 

European Filing & Registration Procedures

 

Lecture 1:

EU Agency Regulatory Structure

Lecture 2:

Registration Options

Lecture 3:

Company Strategy- Linking Clinical Trials & Marketing Authorization Applications

Lecture 4:

Balancing Strategy and Long Term Regulatory Cost & Maintenance

Lecture 5:

Registration Procedures

  • Member State Procedures
  • Mutual Recognition Procedure
  • Centralized Procedure

Lecture 6:

Abridged Applications

  • Similar Products & Devices
  • Request for Extensions
  • Use of Expert Reports

Lecture 7:

Generics, Orphan Drugs, Biologics and Combination Products

Lecture 8:

Variations

  • Changes Concerning Manufacturing Aspects (Product & Process)
  • Labeling & Packaging Leaflet Requirements
  • EU Commission Regulations

Lecture 9:

Decision Making Process

  • Scope
  • Check-in Procedure
  • Internal Commission
  • Consultation
  • Industry's Ability to Impact?- Involvement & Timing
  • Standing Committee Participation
  • Favorable Standing Committee Opinion
  • Non-Favorable Opinion ?- Process & Timing

Lecture 10:

Review of Regulatory Authorities

  • International, Regional, and Local laws applicable for each European Union Nation

Lecture 11:

Member State Analysis of Applicable Regulations At All Levels With Practical Examples of How the Regulations Are Applied

  • Legislative Process
  • Objectives of the Rules Governing Medicinal Procedures
  • Regulatory Framework
  • New Products, Requirements, & Procedures

Lecture 12:

Political Implications of The Regulations

  • Compare/Contrast EMA and the FDA procedures

Lecture 13:

How and When to Influence the Regulatory Process

  • Effective Monitoring Activity
  • Association vs. Individual Company Involvement & Intervention
  • The Regulatory Negotiation Process
  • Effective Approaches
  • The Do's and Don'ts of Regulatory Involvement

Lecture 14:

How to Use Regulations / Regulatory Contacts to Your Advantage

  • Check-in Procedure
  • Internal Commission Interactions
  • Procedures within each regulatory office, contacts, etc.
    • Product Development Strategy
  • Business Impact Within and Outside the EU
  • Professionalism in Regulatory Lobbying

Lecture 15:

Maintaining Your License: Renewals

Lecture 16:

Helpful Websites

Lecture 17:

Glossary of Terms

 

Speaker

Robert Russell

President, RJR Consulting, Inc. 

For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.

 

Location: Zurich, Switzerland Date:  November 2nd & 3rd, 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:

 

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

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

Register now and save $200. (Early Bird)

Until September 15, Early Bird Price: $1,695.00 From September 16 to October 31, Regular Price: $1,895.00

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

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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=901354SEMINAR?findcpd-November-2017-SEO

 

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126213| MentorHealth| HIPAA and Health IT - What you Need to Know as a Business Associate|

Training Options Duration: 60 Minutes
Wednesday, October 25, 2017 | 10:00 AM PDT | 01:00 PM EDT

Overview: As defined by the Health Information Portability and Accountability Act (HIPAA), a Business Associate can be any organization or person working in association with or providing services to a Covered Entity who handles or discloses Protected Health Information (PHI) or Personal Health Records (PHR). With certain exceptions, a person or entity that creates, receives, maintains, or transmits PHI for a function or activity regulated by the HIPAA Privacy Rule for a Covered Entity is a Business Associate.

The HITECH Act, a recent update made to overall HIPAA regulations require Business Associates to comply with HIPAA mandates regarding the handling and use of health information. As a Business Associate you must comply with a wide-range of regulatory obligations, including certain privacy obligations, security standards, and breach notification requirements.

If your business needs to understand what it means to be a Business Associate and know what required safeguards, policies and procedures must be in place or make sure your current compliance program is adequate and can withstand government scrutiny, please join us for this informative and interactive session.

Why should you Attend: There is a lot of confusion about the role and requirements of being a Business Associate. Organizations must be prepared prior to entering into these contracts for services as a vendor and subcontractor.

Attendees will leave the course clearly understanding of all the requirements that must be in place for the Business Associate - Covered Entity arrangement. After completing this course, a Business Associate will have a clear understanding as to what needs to be place when it comes to all of the HIPAA regulations.

Areas Covered in the Session:

Why was HIPAA created?
Who Must Comply with HIPAA Requirements?
What are the HIPAA Security and Privacy Rules?
What are the Consequences of being a Business Associate
What is a HIPAA Compliance Program?
What is a HIPAA Risk Management Plan?
What is a HIPAA Risk Assessment?
What is the Role of the HIPAA Security Official?
What are HIPAA training requirements?
What is a HIPAA data breach and what happens if it occurs?
What are the penalties and fines for non-compliance and how to avoid them
Case Examples of HIPAA Data Breaches
Creating a Culture of Compliance

Who Will Benefit:

HIPAA Privacy Officer
HIPAA Security Officer
Health Information Technology Vendors and Staff
Third party administrators that assist health plans with claims processing
CPA firms whose accounting services to a health care provider involve access to protected health information
Pharmacy benefits managers that manages a health plan’s pharmacist network
Consultants that performs utilization reviews for hospitals
Vendor of Personal Health Records
Information Systems Manager
Chief Information Officer
General Counsel/Lawyer
Office Manager

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

Contact Info:
Netzealous LLC -MentorHealth
Phone No: 1-800-385-1607
Fax: 302-288-6884
Email: support@mentorhealth.com
Website: http://www.mentorhealth.com/
Webinar Sponsorship: https://www.mentorhealth.com/control/webinar-sponsorship/

 

126212| MentorHealth| Recruiting and Retaining Hispanic Patients for Clinical Trials|

Training Options Duration: 60 Minutes
Wednesday, October 25, 2017 | 10:00 AM PDT | 01:00 PM EDT

Overview: Hispanic patients usually prefer to take care of their basic medical needs in solo practitioners' offices and small medical centers. where they find the respect and attention that large establishments deny them. Renowned experts of Quality in Health care have been critical of the current design and implementation of randomized clinical trials, the gold standard of clinical research, because they believe that they often, but not always, presume a linear, mechanistic system when in fact improvement in Health care takes place within complex adaptive systems that evolve.

They claim that care interventions must adapt to difficult contexts, which are often at odds with the concept of improvement health care delivery as a fixed set of activities, which can be studied through controlled clinical trials. We believe that the design and implementation of modern clinical trials must take into account the complexity and diversity of our patient populations and their different responses to the continuity of care and monitoring techniques. Not only there is need for evidence-based practice but also for "practice based evidence" that allow flexible learning to obtain acceptable outcomes. In a continuous loop that starts in the first stages of clinical research, goes through all the different stages of clinical trials, continues in the clinical care settings and goes back to the minds that initially proposed the studies, all the different actors and participants feed each other with positive feedback info. The combined action of ignorance and prejudice can impair the efficient recruitment and retaining of "different people" like Hispanics that have long suffered sustained, mendacious discrimination in their access to basic health care services for care and prevention of diseases.

The front desk staff is always the first responder to their particular needs, often expressed in non-traditional forms of expression, and should be carefully trained to avoid the most common pitfalls and misunderstandings. III The professionals-nurses, technicians, physicians-in direct contact with these patients must anticipate the emergency of some controversial issues and negative feedback that can, and will, sabotage a continued participation. The constrictive corset of political correctness in our society can discourage the honest discussion and remedy of critical issues such as patient apathy, dishonesty, and more commonly a claimed ignorance of GPC guidelines. Reacting to the longstanding critique that the clinical trials are skewed to favour the participation of only certain segments of the population, the FDA has enacted an "Action plan to enhance the Collection and Availability of Demographic subgroup data" in order to prodd the inclusion of Minority patients in the design and implementation of clinical research.

Why should you Attend: Based on our long experience of treating Hispanic and patients in "New Life Medical Center", a Primary Care and Community Mental Health center in Miami, Florida, we will discuss the more common obstacles found in the final pursuit of good clinical outcomes for them. We will focus on the practical steps to assure an effective and equitable approach for the health care needs of these patients and the unbiased monitoring for compliance with internationally accepted regulations. As health care practitioners and administrators that must respond quickly to a changing health care arena, we will discuss case studies and enact role plays to illustrate the most common problems and the needed solutions.

Areas Covered in the Session:

Distinguish the more common scenarios that jeopardize the proper recruitment and participation of Hispanics
Illustrate with case studies the counterproductive arguments and enticements in the approach to non-cooperative Hispanics
Describe the basic tenets of Competency CLAS guidelines in a changing and polymorphous health care arena in our modern society

Who Will Benefit:
Physicians
Nurses
Technicians
Office Managers
Administrators

Speaker Profile
Dr. Mario O. Laplume was born on November 5th 1954 in Montevideo, Uruguay. He did his primary school studies in the “Lycée Français” and his secondary ones in the “Liceo No.5 José Pedro Varela.” In a parallel way he studied French in the “Alliance Francaise” and English in the “Instituto Anglo-Uruguayo.” In 1972 he earned a scholarship as an exchange student from “Youth For Understanding” and spent 6 months in Portage, Michigan. He studied Medicine in the “Universidad Nacional de La Plata” in La Plata, Argentina, from 1974 to 1981 when he graduated with the title of “Médico.”

He passed the ECFMG examinations in December 1982 and he did a Surgical Internship in “Lutheran Medical Center” in New York City. He did his post-graduate Neurology training in the “University of South Alabama” in Mobile, Alabama, in 1984 and 1985. He worked in “Coral Way Medical Associates”, a multi-specialty group in Miami, from 1986 to 2008, becoming its medical director in September 1998 until its final dissolution. From September 1996 to May 2008 he studied Master and Doctoral degrees in Public Health at “Columbia University in the City of New York”, earning his degrees in 1998 and 2008. His doctoral thesis is centred on the “Socio-Sanitary integration of the Regione Veneto” of Italy. From May 2008 up to the present time he has worked as an independent consultant in “Health Policy and Management” for various South Florida medical institutions.

Price - $139

Contact Info:
Netzealous LLC -MentorHealth
Phone No: 1-800-385-1607
Fax: 302-288-6884
Email: support@mentorhealth.com
Website: http://www.mentorhealth.com/
Webinar Sponsorship: https://www.mentorhealth.com/control/webinar-sponsorship/

126211| MentorHealth| New Guidance on De-Identifying Protected Health Information under HIPAA|

Training Options Duration: 90 Minutes
Tuesday, October 24, 2017 | 10:00 AM PDT | 01:00 PM EDT

Overview: This webinar will be addressing the ins and outs of identifying what is and what is not PHI, proper ways to disclose this information, common sense security methods, what we can and can't do under HIPAA relating to disclosures, and how to properly investigate a breach (or a suspected breach). We will also 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 relating to protected health information Additional 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 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: Are you clear on what constitutes identifiable health information vs none identifiable health information? It can be very confusing and frustrating to say the least. Since the HIPAA Omnibus Final ruling, the Federal government has expanded the definition of what constituted PHI.

Is your staff trained to understand the new risks and definitions?
Do you have written policy in place relating to this?
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:
What is PHI
What constitutes identifiable PHI
What is "de-indentified" PHI
How to investigate a possible breach and conclude whether the incident constituted a breach or not
How to properly notify if a breach occurs
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 LLC -MentorHealth
Phone No: 1-800-385-1607
Fax: 302-288-6884
Email: support@mentorhealth.com
Website: http://www.mentorhealth.com/
Webinar Sponsorship: https://www.mentorhealth.com/control/webinar-sponsorship/

 

126210| MentorHealth| Workplace Violence Plans, Policies & Procedures for Hospitals & Healthcare Facilities|

Training Options Duration: 90 Minutes
Wednesday, October 18, 2017 | 10:00 AM PDT | 01:00 PM EDT


Overview: How safe is your healthcare facility from workplace violence? Workplace violence against healthcare workers can be significantly reduced with a comprehensive violence prevention program. This webinar will outline common risk factors for violence, the basics elements of a violence prevention program and strategies for responding to violent events when they occur. The importance of training nurses and other healthcare workers in recognizing and managing aggressive behavior will be emphasized.

This webinar, presented by a recognized expert on workplace violence prevention, will familiarize participants with the ways by which healthcare organizations can ensure physical safety for its employees by preparing in advance.

Why should you Attend: Violence against health workers should never be considered as being acceptable or "just part of the job." Not only is there a negative impact on the psychological and physical well being of health-care staff, but also affects their job motivation. The consequence of violence impacts the quality of care and may lead to major financial losses to a healthcare organization. These may include but are not limited to:

Sanctions and fines from OSHA and other government agencies
Additional difficulties maintaining credentials for the Joint Commission and other credentialing groups
Increased difficulties in hiring and keeping good employees
Higher insurance premiums
Lawsuits by employees and other victims
Lower employee morale
Disruption in operations for extended periods of time for crime scene clean up and investigation

Many factors place healthcare workers above average risk for violence; they care for people with histories of violent behavior, who may be under the influence of drugs, or who may be delirious from medications, narcotics, or a medical condition such as dementia.

Areas Covered in the Session:
Scope and Impact of Workplace Violence in the Healthcare Setting
The Four Types of Workplace Violence and Their Associated Risk Factors
Elements of an Effective Workplace Violence Program
Worksite Hazard Analysis
Universal Precautions for Violence

Who Will Benefit:
Risk Management
Security Directors, Managers & Officers
Education Professionals
Compliance Professionals
Safety Managers, Directors and Officers
Emergency Management Professionals
Members of the safety team

Speaker Profile
Joe Rosner is the Director of Best Defense USA and nationally recognized expert on workplace violence and personal safety for health care and other occupations. He is the author of Street Smarts & Self Defense for Childrenas well books and articles on workplace violence prevention and personal safety for healthcare.

Jo has presented at The National Emergency Management Summit, The American Healthcare Association, The Heartland Healthcare Conference, and numerous state healthcare and hospital conferences. His credentials include multiple black belts, law enforcement, military and bodyguard experience and growing up on the south side of Chicago.

Price - $139

Contact Info:
Netzealous LLC -MentorHealth
Phone No: 1-800-385-1607
Fax: 302-288-6884
Email: support@mentorhealth.com
Website: http://www.mentorhealth.com/
Webinar Sponsorship: https://www.mentorhealth.com/control/webinar-sponsorship/

126209| MentorHealth| De-Identification of PHI under HIPAA - Follow the Guidance to Avoid Penalties|

Training Options Duration: 90 Minutes
Monday, October 16, 2017 | 10:00 AM PDT | 01:00 PM EDT

Overview: Today health information needs to be shared more than ever, but how can that be done most easily within the limits of HIPAA? One way is to de-identify the information. Once PHI has been de-identified, it is no longer protected under HIPAA and may be shared freely without limitation. The problem is that it is not easy to truly de-identify information and if it is not done correctly, the sharing of the information may be considered a breach that requires reporting to HHS and the potential for penalties and corrective action plans.

De-identification of Protected Health Information requires removing all eighteen of the listed identifiers, or anything else that might be used to identify the individual about whom the information exists. Or you can have an expert certify that the information is not identifiable. But neither of these is foolproof. You need to look more closely to be sure the data cannot be identified. You may wish to communicate with another provider, or with an agency that is not covered under HIPAA, using plain e-mail, but you want to strip out the name and use a code that both parties understand. Is that sufficient to allow the use of plain e-mail? You need to run though some examples and some tests to make sure before you go ahead.

The necessity to consider the context of information is essential, especially when the information is unique. A staff member may think a photo of an injury has no identification on it and by itself is not PHI, but if the photo is posted on the staff member's Facebook page shortly after the incident and it's a small town and everyone knows whose injury it is, it's been identified by the context. Sometimes you may need information for research that does not require specific identification of the individual, but does need some information listed in the eighteen identifiers, such as Zip code, dates of birth or death, or dates of treatment. In those cases, often partially de-identified data, known as a Limited Data Set, will suffice, and such data can be used without obtaining an Authorization or approval by a review board. The information must still be protected with HIPAA-quality security, but it can be used for research under a Data Use Agreement.

There are specific steps that you must go through to ensure that if you want to de-identify PHI, you actually do so properly, and that the resulting information is truly de-identified and its use or disclosure will not result in a reportable breach under HIPAA. If you create a Limited Data Set, you need to ensure the proper agreements are in place and the information is transmitted securely. If de-identification or a Limited Data Set are not possible, the appropriate Authorizations or approvals must be in place before sharing the data. This session will explore the concepts and methods of de-identification and many of the typical questions that arise. Attendees will be able to go forward with de-identification with greater confidence, and better sharing of information will be possible.

Why should you Attend: Health information is proliferating and its sharing among health care providers and researchers is necessary for providing health care services and advancing essential health care research. But health information protected under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) is limited in how it can be shared, and when it is shared, is required to be protected.

In some cases, it may be possible to share the needed information more easily once it has been properly de-identified. While a risk analysis would indicate the necessity to encrypt e-mail with Protected Health Information when communicating between providers over the Internet, for instance, if the information is not identifiable, encryption is no longer needed. While releasing information for research purposes may call for a HIPAA Authorization from each patient or approval by review boards and stringent controls on the information, if the research can be done without the identifying data, such Authorizations are reviews are not necessary. But truly de-identifying information is never as simple as it looks. Oftentimes the context of the information or the uniqueness of information can give away the identity. If you use patient initials in an e-mail to identify the individual to the recipient, how unique are those initials? What if the patient's name is Xavier Xanadu -how many individuals have the initials X. X.? If you see information about eight siblings with the same birth date and location, you know it's about the famous Octuplets, because that's the only set of eight you will find.

If information is not properly de-identified and released inappropriately as a result, it can result in fines and corrective action plans that can reach into the millions of dollars. The right process needs to be followed to ensure that data that is shared is shared appropriately, either as identifiable information, as a partially de-identified Limited Data Set, or as properly de-identified information. This session will review guidance from the HHS Office for Civil Rights (OCR) and from the National Institute of Standards and Technology (NIST) about how to properly de-identify health information. The various needs for de-identified information will be discussed and typical questions covered in the guidance will be discussed, in order to provide a sound, defensible basis for an organization's decisions and processes surrounding de-identification of PHI.

Areas Covered in the Session:

De-identification and its Rationale
The De-identification Standard
Preparation for De-identification
Guidance on Satisfying the Expert Determination Method
Who is an expert, how do experts assess the risk of identification of information, what are the approaches by which an expert assesses the risk that health information can be identified, and what are the approaches by which an expert mitigates the risk of identification of an individual in health information
Guidance on Satisfying the Safe Harbor Method

What are examples of dates that are not permitted according to the Safe Harbor Method, what constitutes "any other unique identifying number, characteristic, or code" with respect to the Safe Harbor method of the Privacy Rule, and what is "actual knowledge that the remaining information could be used either alone or in combination with other information to identify an individual who is a subject of the information.

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
Health Care Researcher

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

Contact Info:
Netzealous LLC -MentorHealth
Phone No: 1-800-385-1607
Fax: 302-288-6884
Email: support@mentorhealth.com
Website: http://www.mentorhealth.com/
Webinar Sponsorship: https://www.mentorhealth.com/control/webinar-sponsorship/

126208| MentorHealth| Webinar on HIPAA Requirements for Safeguarding Protected Health Information|

Training Options Duration: 90 Minutes
Thursday, October 12, 2017 | 10:00 AM PDT | 01:00 PM EDT

Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the understanding the fundamentals of a HIPAA compliance.

If your healthcare practice, business, or organization needs to understand what is required to protect health records or make sure your current safeguards are adequate and can withstand government scrutiny, please join us for this informative and interactive course.

Why should you Attend: With a substantial increase HIPAA data breaches, organizations must understand the requirements to safeguard protected health information.

Attendees will leave the course clearly understanding of all the requirements that must be in place for protecting the health records their organizations maintain, create, transmit, or store. After completing this course, a Covered Entity or Business Associate will have a clear understanding for what needs to be place when it comes to all of the HIPAA regulations.

Areas Covered in the Session:

Why was HIPAA created?
Who Must Comply with HIPAA Requirements?
What are the HIPAA Security and Privacy Rules?
What is a HIPAA Risk Management Plan?
What is meant by "Required" and "Addressable" Implementation Specifications?
What are Administrative, Technical, and Physical Safeguards Requirements?
What is a HIPAA Risk Assessment?
What are HIPAA training requirements?
What is a HIPAA data breach and what happens if it occurs?
What are the penalties and fines for non-compliance and how to avoid them?
Creating a Culture of Compliance
Questions

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
Any Business Associates that accesses protected health information
IT Companies that support Medical/Dental practices or other healthcare organizations

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

Contact Info:
Netzealous LLC -MentorHealth
Phone No: 1-800-385-1607
Fax: 302-288-6884
Email: support@mentorhealth.com
Website: http://www.mentorhealth.com/
Webinar Sponsorship: https://www.mentorhealth.com/control/webinar-sponsorship/

126154| NetZealous LLC, DBA TrainHR| Virtual Teams: Managing People Effectively at Multiple Location|

This Course is approved by HRCI and SHRM Recertification Provider

Overview:
Every manager knows that the best - and fastest - way to learn a new skill is through practice. That's why we've packed this hard-hitting workshop with powerful exercises models and case studies specifically designed for managers of multiple locations. This is a unique opportunity to fine-tune your off-site management skills in an environment where you don't have to worry about making a costly mistake. This is your chance to master proven-effective strategies that you can put to work immediately.

When you take part in this workshop, be prepared to roll up your sleeves sweat a little and think a lot. During the session, you'll examine off-site management challenges - and solutions - with peers practice techniques for getting poorly performing locations up-to-speed determine what the pros did right - and wrong - in real-world case studies and much more.

Back at the office, you'll be able to turn around all your off-site concerns. You'll know the inside secrets that'll help you get multiple offices to follow your instructions to the letter accurately monitor quality and build strong, self-reliant teams you can count on.

Why should you Attend:

  • Boost productivity at every location
  • Significantly cut down on paperwork
  • Know off-site employees are following the rules, period, including home-office rules
  • Spot problems even when you're far away

Are you concerned about how much time and productivity your people are wasting?

What about lost energy, efficiency and effectiveness, especially because people are so "spread out"?

Would you like to tame the paper tiger' and reduce so much needless paperwork?

Have you ever been concerned about people "following the rules" you know, out of sight, out of mind'?

Would you like to be able to more effectively spot problems, even when you are hundreds to thousands of miles away?

If you answered "yes" to any of these questions, then come laugh, listen and learn as Chris DeVany leads us all through those important topics, key questions and answers we all need to be able to address effectively to improve our team members' and team's performance, no matter how widely distributed everyone is!

Areas Covered in the Session:

  • Maintain Order While Managing Long-Distance
    • How to give multiple locations a business "road map" that'll keep them headed in the right direction
    • How to create crystal-clear procedures that off-site staff will follow to the letter
    • Expert insight on "friendly" competition between sites could this be doing your company more harm than good?
    • Discuss today's long-distance management challenges and brainstorm possible solutions
    • How to quickly smooth things over when you have to lay down the law and enforce an unpopular policy from a distance
    • The one action you must take if you want to significantly slow down the paper blizzard from multiple locations

 

  • Stay In Touch - And Control - No Matter What
    • How to keep your finger on the pulse of off-site action without making employees feel like "Big Brother" is watching
    • What responsibilities you must shoulder alone and when you can safely share the load with off-site employees
    • A common - but deadly - management mistake that'll ensure an off-site office will never trust your motives
    • Determine the fastest way to get a poorly performing location up to speed
    • How to quickly and accurately check the quality of products or services at any location
    • The inside secrets to creating a lasting bond between off-sites so every employee feels like they're on the same team

 

  • Establish Quality-Minded Teams You Can Rely On
    • How to structure teams so they'll pull together no matter which site they're from
    • How to ease resentment at a satellite location when a home-office employee is chosen for a promotion
    • The only way to handle teams that were established before your time without decreasing productivity
    • How to build an "emergency response" team that'll know what can be handled independently and when to call you immediately

 

  • Troubleshoot Off-Site Problems Like A Pro
    • How often you should be visiting each site any less and you're begging for trouble
    • Phone or face-to-face? The best way to approach a site problem without alienating anyone
    • How to put a stop to childish disputes between sites without taking sides or making matters worse
    • Develop a reward system that'll motivate employees from all levels at every location
    • How to determine whether you should coach counsel or warn the entire staff at a location about their performance
    • An action plan that'll help you handle any "cover-up" you might find no matter how large or small
    • How to ensure the "isolation factor" won't turn into a problem at remote locations


Who Will Benefit:

  • CEO
  • Senior Vice President
  • Vice President
  • Executive Director
  • Managing Director
  • Regional Vice President
  • Area Supervisor
  • Manager

Instructor: Chris DeVany is the founder and president of Pinnacle Performance Improvement Worldwide, a firm which focuses on management and organization development. Pinnacle’s clients include global organizations such as Visa International, Cadence Design Systems, Coca Cola, Sprint, Microsoft, Aviva Insurance, Schlumberger and over 500 other organizations in 22 countries.

 

 


Event link :     http://www.trainhr.com/control/w_product/~product_id=701866LIVE/?channel=findcpd_november_2017_SEO
Contact Details:
NetZealous LLC, DBA TrainHR    
Phone: +1-800-385-1627
Email: support@trainhr.com

126153| NetZealous LLC, DBA TrainHR| Understand what successful leaders know and do that helps them avoid cultural traps and mis-fires|

This Course is approved by HRCI and SHRM Recertification Provider

Overview: Get on a Southwest flight to anywhere, buy shoes from Zappos.com, pants from Nordstrom, groceries from Whole Foods, anything from Costco, a Starbucks espresso, or a Double-Double from In and Out, and you'll get a taste of these brands vibrant cultures.

Unfortunately culture is often misunderstood and discount as a touch feely, rather than a bottom line, component of a business. That's not the case. As Peter Drucker, the founder of modern management said, "Culture eats strategy for lunch." Culture is one of the most important business drivers that has to be intentionally set and periodically adjusted to push long-term, sustainable success. It's not good enough just to have an amazing product and a healthy bank balance. The workplace culture can enable a company's success, or be the key to its undoing.

What about your company's culture? Does it inspire and engage or get in your people's way, slowing and wearing them down? Is it driven from top-down directives or cross-department collaboration? What stories do your people and your customers tell about you? This webinar will show how you can get a good read on the health of your culture.

Why should you Attend:Corporate culture is a hot topic among businesses who want to attract the best talent, translate their values to their products and services, and show customers what they're all about. There are significant benefits that come from a vibrant and impactful culture. They are

  • Focus and Spirit: Aligns the entire company towards achieving its vision, mission, and goals.
  • Engagement:Builds higher employee motivation, productivity, and innovative problem solving.
  • Cohesion:Builds consistency and coordination among the company's various departments and divisions

Also culture often becomes the focus of attention during periods of organizational change. Mergers and acquisitions, new systems implementations and elaborate initiatives typically fail because organizations become caught in the so-called "jaws of culture" when the existing culture becomes inappropriate,and hinders rather than supports progress.

Areas Covered in the Session:

  • Learn why Peter Drucker says Culture eats strategy for lunch
  • Discover why culture is like an iceberg What's above and below the water line
  • Identify and analyze the six key elements of culture in every business or organization
  • Review twelve daily ways effective leaders can communicate and reinforce company culture
  • Plan specific actions you will take to lead or influence changes in the culture of your organization
  • Use a three step process to pinpoint what drives the culture of your team, department or company
  • Understand what successful leaders know and do that helps them avoid cultural traps and mis-fires


Who Will Benefit:

  • CEO's
  • COO's
  • VP of Human Resources
  • Chief Learning Officer
  • Directors
  • Project Managers
  • Operation Managers and Supervisors
  • Team Leaders
  • Human Resources Professionals

Instructor: Marcia Zidle, MS, NCC, BCC is the CEO of Leaders At All Levels and a board certified executive coach based in Dallas Texas. She works with executives, management teams and high potential professionals ON THE MOVE! They want to move up to the next level – ahead of their competition – into new areas – over and around obstacles – beyond business as usual – towards a sustainable future.

 

 


Event link :     http://www.trainhr.com/control/w_product/~product_id=701863LIVE/?channel=findcpd_november_2017_SEO
Contact Details:
NetZealous LLC, DBA TrainHR    
Phone: +1-800-385-1627
Email: support@trainhr.com

126152| NetZealous LLC, DBA TrainHR| Generational Wellness: Engaging the Most Diverse Workforce in History|

This Course is approved by HRCI and SHRM Recertification Provider

Overview: There are more Millennials in the workforce than any other generational cohort. Generation Z already entering the workforce. Additionally, for the first time in history, there are five, very distinct generations working side by side. The way in which these different generations respond to technology, education, communication, and their own health varies drastically. Expecting all generations to respond equally to wellness programs is outdated thinking. This engaging presentation will highlight the defining characteristics of each generation, share interesting research and case studies, while sending you home with concrete strategies to engage a multi-generational population in your wellness program.

Why should you Attend: By attending this webinar, you should walk away with an understanding of the defining characteristics of each generation, make a case for re-thinking communication and relevance in presentation, and go home with concrete strategies to engage a multi-generational population in your wellness program.

Areas Covered in the Session:

  • Identify three broad based strategies to engage a multi-generational workforce in existing wellness strategies
  • Create at least one new wellness initiative using delivery methods that members of all generations can relate to
  • Site the results of at least two scientific studies where the focus was on generational issues related to wellness programs


Who Will Benefit:

  • Human Resource Professionals
  • Benefit Managers
  • Wellness Coordinators
  • Occupational Health Nurses
  • Medical Directors
  • EAP Professionals
  • Health and Safety Directors

Instructor: Dr.Don R.Powell is the President and CEO of the American Institute for Preventive Medicine, a URAC Accredited Wellness company located in Farmington Hills, Michigan.

 

 

 
Event link :    http://www.trainhr.com/control/w_product/~product_id=701861LIVE/~?channel=findcpd_november_2017_SEO
Contact Details:
NetZealous LLC, DBA TrainHR    
Phone: +1-800-385-1627
Email: support@trainhr.com

126151| NetZealous LLC, DBA TrainHR| Project Management Essentials: The 8 Keys To Bring Every Project In On Time and On Budget|

This Course is approved by HRCI and SHRM Recertification Provider

Overview:
How do we manage projects and customer relationships effectively? How do we understand the full scope of a customer "project"? How do we assemble the necessary resources to effectively manage a customer relationship and attendant projects? To whom do we delegate specific responsibilities and when? These are among a number of questions we discuss and about which we learn as we strive to effectively manage projects and the customers whose project we are managing.

Why should you Attend:

  • Understand the essentials of project management
  • Plan for identifying project needs
  • Practice scheduling and teaming
  • Create the necessary plans which will allow you to more effectively manage projects to success
  • Help you to more effectively manage others expectations
  • Keep projects on track
  • Gain knowledge and skills you can apply to all project team situations
  • Keep content, process and structure on track to produce positive outcomes


Would you like to get more (or all!) of the projects you manage in on time and on budget?

Are you concerned about people on your project teams not knowing enough about how to effectively manage a project? What about yourself?

Would you like some help to more effectively manage your projects?

Would you like to more effectively manage others' expectations?

Areas Covered in the Session:

  • Introduction to Project Management
    • What is a Project?
    • What is Project Management?
    • What skills do you need to effectively manage projects?
    • Why is Project Management needed?
    • Leading contributors to Project Success
  • Identifying Needs, Starting Toward Solutions
    • Identifying Stakeholder Needs and Expectations
    • Identifying Business Requirements
    • Performing a Systems Requirements Analysis
    • Performing a Human Resources Analysis
    • Identifying Roles and Responsibilities
    • Creating a Scope Document
    • Gaining Stakeholders Consensus and Approval
  • Scheduling and Teaming
    • Planning
    • Creating a Work Breakdown Structure
    • Performing Risk Management
    • Developing Effort, Time, and Cost Estimates
    • Creating a Project Schedule
    • Creating a Budget
    • Creating a Project Team
  • Management Planning and Execution
    • Creating a Vendor Management Plan
    • Creating a Resource Management Plan
    • Creating a Communication Plan
    • Creating a Quality Management Plan
    • Creating a Project Management Plan
    • Execution
    • Track the Project and Resolve Issues
    • Manage Resources
  • Managing Project Success and Customer Satisfaction Success
    • Managing Quality
    • Managing the Project Team
    • Managing Change
    • Case Study
    • Project Closure
    • Conducting a Customer Acceptance Meeting
    • Conducting a Project Review
    • Identifying the Lessons Learned
    • Compiling a Project Report


Who Will Benefit:

  • CEO
  • Senior Vice President
  • Vice President
  • Executive Director
  • Managing Director
  • Regional Vice President
  • Area Supervisor
  • Manager

Instructor: Chris DeVany is the founder and president of Pinnacle Performance Improvement Worldwide, a firm which focuses on management and organization development. Pinnacle’s clients include global organizations such as Visa International, Cadence Design Systems, Coca Cola, Sprint, Microsoft, Aviva Insurance, Schlumberger and over 500 other organizations in 22 countries.

 

 


Event link :    http://www.trainhr.com/control/w_product/~product_id=701867LIVE/?channel=findcpd_november_2017_SEO
Contact Details:
NetZealous LLC, DBA TrainHR    
Phone: +1-800-385-1627
Email: support@trainhr.com

126150| NetZealous LLC, DBA TrainHR| How to Conduct an Internal Harassment and Bullying Investigation to Determine Facts and Minimize Liability|

This Course is approved by HRCI and SHRM Recertification Provider

 


Overview: The EEOC requires that employers receiving a complaint, or otherwise learning of alleged harassment in the workplace, to "investigate promptly and thoroughly take immediate and appropriate corrective action by doing whatever is necessary to end the harassment, make the victim whole by restoring lost employment benefits or opportunities, and prevent the misconduct from recurring". That's a tall order to ensure a just and fair handling of a harassment complaint - an essential order that all organizations are required, by law, to follow. The investigation process is, perhaps, the most critical element in dealing with harassment. In cases that have gone to court it is often due to inadequate or absent investigations of complaints. Do you know how to conduct an investigation? This program will cover the intricacies of conducting a harassment investigation.

Why should you Attend The investigation is essential in determining the validity to a complaint of protected class harassment and bullying. Conducting a fair and impartial investigation diminishes liability, and can decrease further misconduct by preventing it from becoming pervasive. The investigation may serve to minimize damages paid to the complainant. The institution demonstrates its commitment to the prevention and intervention of the misconduct resulting in less harassment, discrimination and other forms on misconduct on campus. By conducting its own investigation, the institution may avoid an investigation by another agency such as the EEOC. An investigation is required to help ensure a safe and healthy organizational climate.

Anyone who conducts an investigation must be trained in how to do so. Merely having the experience of conducting investigations without having been taught the art and science of the process is not enough. When your organization ensures it is investigator is trained in how to conduct investigations, it demonstrates its commitment to prevention of harassment to the Court or outside agency. The webinar addresses laws that HR is responsible for upholding. When the laws are not followed, it increases the liability for the organization and interferes with a fair and equitable work environment for employees.

Areas Covered in the Session:

  • To determine if an investigation is necessary
  • To discuss the steps of an investigation
  • To explore the intricacies of interviewing the accuser, accused and witnesses
  • To differentiate between a formal and informal investigative procedures
  • To determine credibility of all interviewees
  • To draw conclusions following an investigation
  • To list necessary elements in writing the formal report outlining the investigation


Course Outline:

  • Discussion about if and when an investigation is required
  • Comparison of a formal and informal investigation process
  • Planning for the investigation
  • Review of what Constitutes a Witness
  • Legal Issues Surrounding an Investigation such as Confidentiality, Defamation of Character, and false Imprisonment
  • The importance of Documentation of each Interviewee
  • Examples of Appropriate and Inappropriate Documentation and why it is Critical
  • Specific details regarding how to Corroborate Evidence
  • List of Criteria to determine Credibility of those Interviewed
  • He Said/she Said
  • The Role of the Investigator in forming an opinion following the Investigation
  • How to follow-up with the target, accused, and the organization
  • The critical importance of an investigative report
  • List of Misconduct Triggers that are a catalyst for an Investigation
  • Template Final Report


Who Will Benefit

  • Human Resources professionals - those tasked with investigations such as Generalists, Mangers, and Directors
  • Attorneys
  • HR Consultants

Instructor: Dr. Susan Strauss is a national and international speaker, trainer, consultant and a recognized expert on workplace and school harassment and bullying. She conducts harassment and bullying investigations and functions as an expert witness in harassment and bullying lawsuits. Her clients are from business, education, healthcare, law, and government organizations from both the public and private sector.

 

 

 
Event link :    http://www.trainhr.com/control/w_product/~product_id=701815LIVE/?channel=findcpd_november_2017_SEO
Contact Details:
NetZealous LLC, DBA TrainHR    
Phone: +1-800-385-1627
Email: support@trainhr.com

126149| NetZealous LLC, DBA TrainHR| 6 Most Effective Ways to Deal With Difficult People at Workplace|

This Course is approved by HRCI and SHRM Recertification Provider

 

Overview:
Adjusting your management and personal styles to complement the culture of your work group and your company as a whole can be the catalyst that motivates your teams to heightened productivity. Utilizing extensive practice in the principles of emotional intelligence, Successfully Managing People underscores the importance of self-awareness in developing sensitivity to and better communication with others. You'll leave this 90 Minutes webseminar well versed in the most effective methods for dealing with difficult people winning cooperation and trust and ensuring that your people's values and your organization's goals are in sync.

Why should you Attend:

  • Would you benefit by understanding how to even more effectively motivate and direct the people you rely on?
  • Would you like to be better at delegating?
  • How about an opportunity to understand how to turn difficult people and poor performers into team players?


If you answered "yes" to any of these questions, then come laugh, listen and learn as Chris DeVany leads us all through those important topics, key questions and answers we all need to be able to address effectively to improve our team members' and team's performance!

Areas Covered in the Session:

  • Motivate and direct the employees you rely on-even when they don't share your values
  • Adjust your management and personal style to the needs of different situations
  • Get more done by using the appropriate delegation techniques for any given situation
  • Resolve conflict more effectively in a wide variety of situations
  • Turn difficult people and poor performers into team players
  • Win the cooperation and trust from everyone in your organization
  • Increase your confidence, leadership skills and personal and professional satisfaction in your job
  • Use coaching to guide and direct your team members to improving performance


Who Will Benefit:

  • CEO
  • Senior Vice President
  • Vice President
  • Executive Director
  • Managing Director
  • Regional Vice President
  • Area Supervisor
  • Manager

Instructor: Chris DeVany is the founder and president of Pinnacle Performance Improvement Worldwide, a firm which focuses on management and organization development. Pinnacle’s clients include global organizations such as Visa International, Cadence Design Systems, Coca Cola, Sprint, Microsoft, Aviva Insurance, Schlumberger and over 500 other organizations in 22 countries.

 

 


Event link :    http://www.trainhr.com/control/w_product/~product_id=701870LIVE/?channel=findcpd_november_2017_SEO
Contact Details:
NetZealous LLC, DBA TrainHR    
Phone: +1-800-385-1627
Email: support@trainhr.com

126146| Multiple Locations| Supporting Learning and Assessment in Practice Non-Assessed|

This programme aims to prepare suitably qualified practitioners* to undertake the role of mentor and sign off mentor respectively (NMC 2008:2.1.1). Building on registrant knowledge and skills the course enables participants to reflect on their clinical practice area as a learning environment analysing their personal strengths and developmental needs. The role of the mentor in providing learning opportunities for pre-registration students to achieve clinical competency is examined in theory and in practice through the work-based learning component. 

The importance of recognising individual learning styles is achieved by the application of learning theory to practice. Central to the achievement of the mentorship standards is the recognition of the needs of struggling or failing students. Supportive strategies and networks to provide help for mentors and students are discussed and evaluated.

The course critically examines the role of the mentor in assessing achievement of the NMC standards required for entry to the register (NMC 2010) cross referenced with stage 2 of the NMC Developmental framework NMC (2008: Annex 1).

* Entry Requirements: Applicants must be an NMC Registered Nurse, Midwife or Specialist Community Public Health Nurse (SCPHN) or other registered health care professional with a minimum of 1 year full time or part time equivalent experience.

This module meets the Stage 2 requirements of the NMC Developmental Framework (NMC, 2008).

Those students studying the non-assessed version will have a reduced assessment element, having only to submit their portfolio of evidence, not the accompanying academic writing element.

The student education strategy emerges from the educational philosophy of andragogy and experiential learning theory. Students will be challenged to explore, inquire and strengthen personal and reflective practice. The climate of learning between mentorship students and the course team fosters openness and authenticity. The emphasis throughout the module will be on creating an intrinsically motivated learning experience. 

The aim of the work based learning element of the programme is to provide learning opportunities within the clinical area where students can develop their values, skills and knowledge of mentorship. The work based learning days provide practical opportunities to learn and develop competence producing evidence towards the achievement of the NMC mentorship domains in their own practice environment. Students are given some guidance and suggested activities to support the application of the theory to practice. The work based learning experience has the potential for the student to build up a creative and individualised account of their achievement of the domain competencies.

126147| Multiple Locations| Supporting Learning and Assessment in Practice Non-Assessed|

This programme aims to prepare suitably qualified practitioners* to undertake the role of mentor and sign off mentor respectively (NMC 2008:2.1.1). Building on registrant knowledge and skills the course enables participants to reflect on their clinical practice area as a learning environment analysing their personal strengths and developmental needs. The role of the mentor in providing learning opportunities for pre-registration students to achieve clinical competency is examined in theory and in practice through the work-based learning component. 

The importance of recognising individual learning styles is achieved by the application of learning theory to practice. Central to the achievement of the mentorship standards is the recognition of the needs of struggling or failing students. Supportive strategies and networks to provide help for mentors and students are discussed and evaluated.

The course critically examines the role of the mentor in assessing achievement of the NMC standards required for entry to the register (NMC 2010) cross referenced with stage 2 of the NMC Developmental framework NMC (2008: Annex 1).

* Entry Requirements: Applicants must be an NMC Registered Nurse, Midwife or Specialist Community Public Health Nurse (SCPHN) or other registered health care professional with a minimum of 1 year full time or part time equivalent experience.

This module meets the Stage 2 requirements of the NMC Developmental Framework (NMC, 2008).

Those students studying the non-assessed version will have a reduced assessment element, having only to submit their portfolio of evidence, not the accompanying academic writing element.

The student education strategy emerges from the educational philosophy of andragogy and experiential learning theory. Students will be challenged to explore, inquire and strengthen personal and reflective practice. The climate of learning between mentorship students and the course team fosters openness and authenticity. The emphasis throughout the module will be on creating an intrinsically motivated learning experience. 

The aim of the work based learning element of the programme is to provide learning opportunities within the clinical area where students can develop their values, skills and knowledge of mentorship. The work based learning days provide practical opportunities to learn and develop competence producing evidence towards the achievement of the NMC mentorship domains in their own practice environment. Students are given some guidance and suggested activities to support the application of the theory to practice. The work based learning experience has the potential for the student to build up a creative and individualised account of their achievement of the domain competencies.

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