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  4. Understanding FDA Inspections and Data - 09/06/2023
  1. News & Events for Human Drugs

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

Visit CDER Small Business and Industry Assistance Page

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

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