Webinar: Inspection preparation with a risk-based approach consistent with ICH E6 (R2) requirements
Webinar Recorded July 25, 2018
Presented by Steve Whittaker, Senior Consultant, The Avoca Group, and Grace Crawford, VP Clinical Quality and Compliance, MedImmune.
- Comparison of inspections from different regulatory authorities
- Foci of inspectors
- First-hand experiences of sponsors to uncover common pitfalls
- MHRA’s emphasis on conducting a risk-based analysis
- Compliance with ICH E6 (R2) changes by adapting risk-based tools and methods
- Effect a risk-based approach to inspection readiness with tried and tested strategies
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