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Integration of Manufacturing Quality Assessment and Pre-Approval Inspections
Session Chair(s)
Joanne Wang, PHD
Acting Branch Chief, OPMA, OPQ, CDER
FDA, United States
This session will discuss various case studies that illustrate the mechanism for risk-based holistic assessment of pharmaceutical manufacturing, and how such assessment leads to a thorough and timely assessment.
Learning Objective : Describe the benefits of holistic pharmaceutical manufacturing assessment that involves closer alliance between drug product quality assessment and facility inspection; Recognize manufacturing risks that act as triggers for pre approval inspections.
Speaker(s)
Integrated CMC Review and Inspection for a Combination Product: A Case Study
Nikolas Burlew
Clinipace, United States
Executive VP, RSD Global Consulting
Proposal to Improve Risk-Based Regulatory Application Assessment
Roger Nosal, PHD
Pfizer Inc, United States
Vice President, Head of Global CMC
Regulatory Considerations for Manufacturing Assessment and Pre-Approval Inspections
Derek Smith, PHD
FDA, United States
Director, Div of Inspectional Assessment, OPF, OPQ, CDER