10-Week Risk Management/Risk-Based Quality Management for Clinical Trials Certification Program (Jun 16 - Aug 18, 2023)

10-Week Risk Management/Risk-Based Quality Management for Clinical Trials Certification Program is organized by Barnett International and will be held from Jun 16 - Aug 18, 2023.

Course Description:
Are you prepared for Quality Risk Management (QRM), Risk Management (RM), and Risk-Based Quality Management (RBQM)? With ICH GCP E6 R2 now requiring 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 R2 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 is also reviewed.

The resources required to take this online course are already at your fingertips - an Internet connection and a phone. After registering, you will receive an email confirmation that provides you with the Web Seminar link and audio connection information.

Prior to the start of the course, participants will receive Module 1 materials. Course materials for subsequent modules will be sent weekly prior to class. Come to class prepared to interact – you will be able to ask questions, provide feedback and participate in discussions and group work. 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 R2 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 R2 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, System Level Risks and Project (Clinical Trial) Level 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, S/Logs