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

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