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
Learn more at: www.fda.gov/dr...
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17 окт 2024
