2020 - FDA Inspections: Understanding the Core Elements – Part I

Purpose of FDA Inspections
Some of the Regulations That Apply to Pharmaceuticals of Human Drugs
How Does FDA Decide Who to Inspect?
Inspection Frequency, Relationship to PMAs/NDAs/BLAs and Reference to the Inspection Model
About NIPP
EU and FDA Mutual Recognition Program/ New Inspection Protocol Project (NIPP)/ Risk Factors
FDA Enforcements
Example of DOJ Pharma/Device Settlements
How Does “QSIT” Relate to the Pharmaceutical Industry
Preparation for an FDA Inspection
Inspection Process: What to Expect From FDA’s Arrival Up to Their Exit
Timelines to Respond to 483s and Warning Letters and Sequence of Response
Inspection Observations/Findings-Trends
Examples of Inspectional Findings on Warning Letters
Challenges
Conclusions