Understanding FDA Inspections and Data

FDA provides an overview of drug manufacturing inspections; a general understanding of Current Good Manufacturing Practices (CGMPs) and FDA Inspections; and demonstrates where inspection data is found on FDA’s website and share how to navigate the FDA Inspection Dashboard.

Timestamps

01:35 – Applicable Manufacturing Standards

10:22 – Understanding CGMP Inspections and 483s

24:39 – FDA Regulatory Actions & How FDA Reviews Inspectional Findings

39:21 – Where to Find Inspection & Other Compliance Documents

41:45 – FDA Inspections Dashboard Demo

49:04 – Q&A Discussion Panel

Speakers | Panelists:

Jennifer Maguire
Director, Office of Quality Surveillance (OQS)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
FDA

Simone Pitts
Pharmaceutical National Expert
Office of Regulatory Affairs (ORA) | FDA

Francis Godwin
Director, Office of Manufacturing Quality (OMQ)
Office of Compliance (OC) | CDER | FDA

Darshini Satchi
Deputy Director, Division of Information Disclosure Policy (DIDP)
Office of Regulatory Programs (ORP) | CDER | FDA

Rob Bughman
Project Manager, FDA Inspection Dashboard
ORA | FDA

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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.

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