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Session 6 Track 3: Inspection Readiness: Different Approaches to Inspection Readiness with Real-World Case Studies and Inspection Outcomes from Sponsors
Session Chair(s)
Jamie O'Keefe
Head, Clinical & Regulatory Consulting
Astrix, United States
Discussion on the approaches to inspection readiness with real-world case studies and inspection outcomes from sponsors. We will discuss different approaches to study level inspection readiness:
- Reactive: Based upon an anticipation of an audit or audit request, performing IR reviews, identifying gaps and issues, and taking a risk based approach to remediation and storyboarding
- Pro-active: Establishing Inspection Readiness processes and a culture of inspection readiness throughout clinical trial management, and implementing across all studies
- Hybrid: Based upon an understanding that certain programs are not inspection ready, execute an IR review program, and leverage the findings to not only remediate the specific programs, but establish new processes and culture across the portfolio
Learning Objective : At the conclusion of this session, participants should be able to:
- Define Inspection Readiness
- Compare and contrast the pros and cons of different approaches to Inspection Readiness
- Choose the best approach for your organization
Speaker(s)
Speaker
Donna Dorozinsky, BSN, MSN
Just in Time GCP, United States
President & CEO
Speaker
Jaclyn Verrow
Vertex Pharmaceuticals, United States
Director, Clinical Quality Management
Speaker
Gabriela Stanescu, RN
Chiesi Canada Corporation, Canada
Lead Clinical Project Manager
Speaker
Jamie Toth, MS
Beigene, United States
Global Head, TMF Management & Records
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