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:
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Compare inspections from different regulatory authorities
- Foci of inspectors
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What they inspected and didn’t inspect to determine compliance
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First-hand experiences of sponsors to uncover common pitfalls
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MHRA’s emphasis on conducting a risk-based analysis
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Study case examples
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Comply with ICH E6 (R2) changes by adapting risk-based tools and methods
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Effect a risk-based approach to inspection readiness with tried and tested strategies
Presenters:
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Steve Whittaker
Executive Director, Avoca Quality Consortium Senior Consultant, The Avoca Group
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Grace Crawford
VP Clinical Quality and Compliance, MedImmune |
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