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2020 - Preparing for a US FDA CGMP Compliance Audit Under 21 CFR 210, 211 and 820



VenueOnline event, USA - United States USA - United States

KeywordsCgmps; Iso 13485; 21 cfr 820; 21 cfr 11


Topics/Call fo Papers

Basic U.S. FDA's expectations – the CGMPs; what is the FDA “thinking”
Tougher FDA Expectations / Requirements
Avoid complacency from past "good" FDA / Notified Body / ISO audits
Key pharmaceutical CGMP concerns
Key medical device CGMP concerns
Other / associated inspection issues
What to expect before, during and after a US FDA CGMP inspection
Important and required post-inspection actions

Last modified: 2020-07-14 20:32:22