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Archive: Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance
The most profound change in the updated ICH GCP E6 R2 is the new sponsor responsibility, Section 5.0, Quality Management. This section provides detail on implementing a system of quality management; critical process and data identification; risk identification; risk evaluation; risk control; risk communication; risk review; and risk reporting. Further, risk assessment and risk mitigation plans are required, regardless of whether Risk-Based Quality Management (RBQM) is being utilized by the sponsor. These requirements also address: Efficient clinical trial protocol design; data collection tools/ procedures; and, collection of information that is essential to decision making. This web seminar takes an in-depth look at the updated guideline with respect to quality management, as well as the methodology of RBQM. How to apply these guidelines in a step-by-step process with strategies for effective implementation will be reviewed and an example provided.
- Define the three-way risk evaluation methodology
- Distinguish between the concepts of risk mitigation and risk acceptance
- Describe the concept of “predefined tolerance limits”
- Describe centralized monitoring
- Define a best practice implementation process based on practical experience
Who Should Attend
- Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management
- Study Managers/Project Managers, Clinical Research Associates/Monitors (Centralized, On-site)
- Business Process Owners
Elizabeth Ronk Nelson, M.P.H.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.