Course Description

Are you prepared for Quality Risk Management (QRM), Risk Management (RM), Risk-Based Quality Management (RBQM)? With ICH GCP E6 R3 in the final draft stage the guideline still requires risk-based approaches to managing quality in clinical trials, this 10-Week series takes you through, step-by-step, how to execute these requirements. We will focus on the critical elements for clinical trial sponsors and CROs included in the ICH GCP E6 R3 expectations, while highlighting key points from other regulatory bodies such as ISO 31000 Risk Management. Each step of risk identification, assessment, control, review, reporting, management, and communication are also reviewed along with what is to be documented in the clinical study report.

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives

• Describe the expectations of QRM in relation to the ICH E6 R3 planned updates
• Discuss how to analyze risks and develop a risk register
• Describe how to use multiple risk analysis tools including: Failure Mode Effect Analysis (FMEA), Bow Tie, and Affinity Diagram
• Describe how to formulate risk mitigation strategies

Course Outline

• Module 1: Quality Risk Management: Quality Risk Management/ Risk Management (ICH GCP E6 R3 and ISO 31000), Risk Management Policy/ Program, Accountability and Resources
• Module 2:Risk Management Plan and Culture: Framework for Communicating Risk Within an Organization/Program, Strategies and Challenges for Risk Stakeholders, Required Commitment and Mandate
• Module 3: Risk Identification: Risk Identification and When to Start, Protocol Risks, Risk Register (Risk Log) for Tracking Risks
• Module 4: Risk Evaluation: Impact of Error, Detection of the Error, Risk Priority Number (RPN) Values
• Module 5: Risk Analysis Tools Part I: FMEA, Bow Tie, and Delphi technique
• Module 6:Risk Analysis Tools Part II: SWOT (Strengths, Weakness, Opportunities, Threats), Affinity Diagram, Cause and Effect Analysis
• Module 7: Risk Control: Risk Mitigation Strategies, Risk Mitigation Options, Priority Rankings of Risk Mitigation Plans
• Module 8: Risk Communication: Risk Mitigation Plans in the Risk Register/Log, Impact of Internal and External Stakeholders, Escalation Processes and Plans
• Module 9: Risk Review: Periodic Review, Risk Assessment, and Risk Detection
• Module 10: Risk Reporting: Risks, Deviations, Predefined Quality Tolerance Limits, Lessons Learned/Continuous Learning, Required Documentation in the Clinical Study Report

Who Should Attend

• Quality Control/Assurance Professionals
• Regulatory Affairs Professionals
• Clinical Research/Operations Personnel
• Information Technology/Security Personnel
• Data Managers
• Study Managers
• Project Physicians/Medical Monitors
• Pharmacovigilance Professionals
• Biostatisticians

NOTE: This course is for individual registrants only and does not allow for group training.

What previous students have said ...

“This course is beyond my expectation with very practical examples and tools. Both instructors are excellent with great attention to address participants’ questions.”

"The course was well designed. These lessons were valuable in seeing the big picture of clinical research."

“The tools provided were great. I hope to use the risk log and risk analysis tools.”

Instructor

The course will be led by one of the following instructors:

Susan M. Leister, M.B.A., Ph.D., CQA, CSSBB

Shelia Russell McCullers, M.S., D.M.

Click here for complete trainer biographies

Course Length and Time

10 weeks for 2 hours each week.

Registration Fees

$1,695 by Early Bird Deadline

$1,895 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 20 hours (2.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-23-005-L99-P. Released: 4/23.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.