CyntegrityEDU - ICH GCP E6 R2 Gap Analysis Webinar

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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