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FDA Drug Manufacturing Inspections - REdI 2020

FDA discusses the purposes, conduct, and expectations of FDA drug manufacturing inspections. The presentation covers how to prepare for, host, and respond to such inspections, as well as the inspection’s potential consequences. Presenter: Russell K. Riley, Compliance Officer Division of Pharmaceutical Quality Operations III| Office of Regulatory Affairs (ORA) | FDA _______________________________ FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming training and free continuing education credits: https://www.fda.gov/cdersbia CDER SBIA 2020 Playlist:    • 2020 CDER Small Business and Industry...   LinkedIn:   / cder-small-business-and-industry-assistance   Training resources: https://www.fda.gov/cderbsbialearn Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm... Email: [email protected] Phone: (301) 796-6707 I (866) 405-5367