Pre-Approval Inspections: What to Expect When Being Inspected (15of15) REdI – May 29-30, 2019
5.3 هزار بار بازدید -
4 سال پیش
-
Sean Marcsisin from the FDA
Sean Marcsisin from the FDA Office of Regulatory Affairs explains the pre-approval inspectional process. He discusses what triggers an inspection, items that are evaluated during an inspection, and common pre-approval inspectional concerns.
Learn more at https://www.fda.gov/drugs/cder-small-...
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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.
Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities.
Email: [email protected]
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn: LinkedIn: cder-small-business-and-industry-assistance
Twitter: Twitter: FDA_Drug_Info
CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...
Learn more at https://www.fda.gov/drugs/cder-small-...
_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities.
Email: [email protected]
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn: LinkedIn: cder-small-business-and-industry-assistance
Twitter: Twitter: FDA_Drug_Info
CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...
4 سال پیش
در تاریخ 1399/01/08 منتشر شده
است.
5,367
بـار بازدید شده