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Inspections and Use of Alternate Tools During the COVID-19 Public Health Emergency + Q/A Panel

Laurie Graham, Director for the Division of Internal Policies and Procedures, discusses site inspections, use of alternate tools, and the impact of travel restrictions during the COVID-19 Public Health Emergency (PHE).

This recording also includes a question and answer panel, also including Derek Smith, Deputy Director of the Office Pharmaceutical Manufacturing Assessment; CDER Tara Gooen Bizjak, Director of the Manufacturing Quality Guidance and Policy Staff; Alonza Cruse, Director of the Office of Pharmaceutical Quality Operations; and Neil Stiber, Associate Director of the Office of Quality Surveillance.

Panel discussion includes
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/manufacturing-supply-chain-and-inspections-during-covid19-public-health-emergency-08252021-08252021
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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.  

Upcoming Training – https://www.fda.gov/cdersbia
SBIA Listserv – https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2021 Playlist – https://youtube.com/playlist?list=PLey4Qe-UxcxYS1MaTusSgyifQDqdeepyD
SBIA LinkedIn – https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources – https://www.fda.gov/cdersbialearn
Twitter – https://twitter.com/FDA_Drug_Info
Email – CDERSBIA@fda.hhs.gov  
Phone – (301) 796-6707 I (866) 405-5367

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