CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) Addendum: January 22, 2018 Course


Date: January 22, 2018

Time: 11:00 am – 12:30 pm EST

Duration: 90 minutes

Sponsored by: Life Science Training Institute

Webinar: Live interactive session and recorded

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ICH E6(R2) Addendum strengthens the responsibility for sponsors to assure protocol compliance and to develop effective strategies for noncompliance. According to the addendum, “If noncompliance that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results is discovered, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions” (5.20).

Join our own Sandra “SAM” Sather for this interactive training session on the essentials of Corrective and Preventive Actions (CAPA) and Root Cause Analysis (RCA). Learn how the recent changes to GCP affect your application strategies.

Key takeaway benefits:

  • Overview of how to successfully perform a Root Cause Analysis
  • Determine appropriate use of RCA through use-case examples
  • Suggestions for action planning that support application strategies
  • Understanding that “practice is essential” for CAPA and RCA to be successful

- The Clinical Pathways Team

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