Virtual | Virtual

Event Title

Understanding FDA Inspections and Data

September 6, 2023

Date:: September 6, 2023
Time:: 1:00 PM - 3:00 PM ET

Topics & Presentations	Speakers
Understanding FDA Inspections and Data
Applicable Manufacturing Standards	Jennifer Maguire Director, Office of Quality Surveillance (OQS) Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) FDA
Understanding CGMP Inspections and 483s	Simone Pitts Pharmaceutical National Expert Office of Regulatory Affairs (ORA) \| FDA
FDA Regulatory Actions & How FDA Reviews Inspectional Findings	Francis Godwin Director, Office of Manufacturing Quality (OMQ) Office of Compliance (OC) \| CDER \| FDA
Where to Find Inspection & Other Compliance Documents:	Darshini Satchi Deputy Director, Division of Information Disclosure Policy (DIDP) Office of Regulatory Programs (ORP) \| CDER \| FDA
FDA Inspections Dashboard Demo	Rob Bughman Project Manager, FDA Inspection Dashboard ORA \| FDA
Q&A Discussion Panel	Same as above

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ABOUT THIS EVENT

During this webinar FDA will provide an overview of drug manufacturing inspections. Participants will gain a general understanding of Current Good Manufacturing Practices (CGMPs) and FDA Inspections. FDA subject matter experts will also demonstrate where inspection data is found on FDA’s website and share how to navigate the FDA Inspection Dashboard.

INTENDED AUDIENCE

Regulatory science and regulatory affairs professionals
Healthcare organizations that purchase pharmaceuticals

TOPICS COVERED

Overview of FDA’s CGMPs and Inspection Practices
How to Find FDA Inspectional Findings

FDA RESOURCES

Event Materials

Title	File Type/Size
Understanding FDA Inspections and Data_September 06, 2023.pdf	pdf (981.83 KB)