This symposium, held every two years, explored topics related to pharmaceutical quality regulation, supply chains, and advanced manufacturing technologies.

Timestamps

00:01 – Inspections in a Post-Pandemic World

13:58 – Pre-license Inspections: What Industry Should Know

30:16 – Q&A Discussion Panel

Speakers | Panelists:

Alonza Cruse
Director
Office of Pharmaceutical Quality Operations (OPQO)
Office of Regulatory Affairs (ORA) | FDA

Christopher Downey, PhD
Supervisory Chemist
Office of Pharmaceutical Manufacturing Assessment (OPMA)
Office of Pharmaceutical Quality (OPQ) | CDER

Learn more at: [ Ссылка ]

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367

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