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 Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/understanding-fda-inspections-and-data-09062023 ----------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352 SBIA 2022 Playlist - https://www.youtube.com/playlist?list=PLey4Qe-UxcxbzCGn90m38cXN2DL2i3VmD SBIA LinkedIn - https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter - https://twitter.com/FDA_Drug_Info Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367