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AQC Member-only Webinar

Inspection Preparation With a Risk-Based Approach Consistent with ICH E6 (R2) Requirements

Recorded Wednesday, March 21, 2018  |  11:00am – 12:00pm EDT


Click here to view the webinar recording and slides >>

AQC Member credentials are required to access the above link. To request credentials, please contact us.


Webinar Agenda:

  • Compare inspections from different regulatory authorities
  • Foci of inspectors
    • What they inspected and didn’t inspect to determine compliance
  • First-hand experiences of sponsors to uncover common pitfalls
  • MHRA’s emphasis on conducting a risk-based analysis
    • Study case examples
  • Comply 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




Steve Whittaker

Executive Director, Avoca Quality Consortium

Senior Consultant, The Avoca Group


Grace Crawford

VP Clinical Quality and Compliance, MedImmune


Need more information? Contact us with your questions or to schedule a consultation.