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Session 2A: Joint Inspections
Session Chair(s)
Zedong Dong, PhD
Quality Assessment Lead (Acting)
FDA, United States
Frequently, new drug applications and post-approval CMC changes may require facility inspections. In addition to the investigator(s), reviewers and subject matter experts may also participate in the audit. Speakers from regulatory agencies and industry will share their knowledge and experience on manufacturing facility inspections. A brief panel discussion will follow to address your questions and discuss approaches for a successful inspection from both the regulatory and industry perspectives.
Speaker(s)
CDER Participation on Pre-Approval and Post-Approval Inspections
Thuy M Nguyen, MPH
FDA, United States
Project Manager
Pre-Approval and Post-Approval Inspections – ORA Role
Sharon K. Thoma, PharmD, RPh
FDA, United States
National Expert of Pharmaceutical Inspections, ORA, OMPTO
Development and Current State of Joint Inspections: Review and Inspection- Industry Perspective
Joseph Famulare
Genentech, A Member of the Roche Group, United States
Vice President, Global Compliance and External Collaboration
Joint Review and Inspection, an Industry Perspective
John Groskoph, MBA
Pfizer Inc, United States
Executive Director, Global CMC
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