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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

SPEAKERS | PANELISTS

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

FDA RESOURCES

• CDER Reading Room
• ORA Reading Room
• FDA Warning Letter Page
• FDA Inspections Dashboard
• FDA CGMP Inspection Related Import Alert
• Enforcement Reports