ICH GCP E6 R2 Gap Analysis | Andy Lawton

Описание к видео ICH GCP E6 R2 Gap Analysis | Andy Lawton

Topics discussed during the webinar:

- What gaps do you still have in your current quality assurance, monitoring, and oversight?
- ICH E6 (R2) history, changes, and scope.
- What is risk-based quality management?
- How to apply quality tolerance limits?
- How to create an efficient risk-based monitoring plan?
- How to conduct electronic media validation?
- Data collection and reporting procedures.
- Computerized systems, validation.
- Investigator responsibilities.
- A delegation of tasks and essential documents.
- How to Embrace E6 (R2) Addendum?

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