What to Expect after an Inspection: 483s, Responses and Beyond скачать в хорошем качестве

What to Expect after an Inspection: 483s, Responses and Beyond

During this webinar, FDA provided an overview of what to expect after a compounding inspection. FDA discussed the intent of an FDA Form 483, ‘Inspectional Observation,’ compounding inspection closeout meetings, post-inspection expectations and regulatory responses, and provided a few examples to help explain how best to respond to an FDA Form 483 observation after a compounding inspection. Timestamps 07:07 – Rebecca Asente, MS, RD - What to Expect After an Inspection 31:02 – Jennifer DelValleOrtiz, MS - Discussion of Examples 42:58 – Q&A Discussion Panel 59:16 – FDA Compounding Quality Center of Excellence Speakers: Rebecca Asente, MS, RD Compliance Officer Office of Pharmaceutical Quality Operations (OPQO) Office of Regulatory Affairs (ORA) | US FDA Jennifer DelValleOrtiz, MS Supervisory Consumer Safety Officer Division of Compounding I (DC1) Office of Compounding Quality & Compliance (OCQC) Office of Compliance (OC) Center for Drug Evaluation and Research (CDER) | US FDA Jill Hammond Captain, US Public Health Service Program Manager Office of Compounding Quality & Compliance (OCQC) Office of Compliance (OC) Center for Drug Evaluation and Research (CDER)| US FDA Panelists: Rebecca Asente and Jennifer DelValleOrtiz Learn more at: https://www.fda.gov/drugs/news-events... ----------------------- 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/accoun... SBIA 2022 Playlist -    • 2022 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367