How Does FDA Execute Pre- and Post-approval Inspections? (7of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration
U.S. Food and Drug Administration
3.3 هزار بار بازدید - 5 سال پیش - Rakhi B. Shah from CDER’s
Rakhi B. Shah from CDER’s Office of Pharmaceutical Quality reviews the FDA’s decision-making process for recommending pre-approval and post-approval inspections. Shah also covers how FDA executes these inspections in the field and common pitfalls found at facilities. Learn more at: https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/regulatory-education-industry-redi-pharmaceutical-quality-symposium-oct-16-17-2019 _______________________________ 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: https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance Twitter: https://twitter.com/FDA_Drug_Info CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionmanagement
5 سال پیش در تاریخ 1399/01/15 منتشر شده است.
3,317 بـار بازدید شده
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