What to Expect after an Inspection: 483s, Responses and Beyond
6.6 هزار بار بازدید -
2 سال پیش
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During this webinar, FDA provided
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...
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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...
SBIA LinkedIn - LinkedIn: cder-small-business-and-industry-assistance
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter - Twitter: FDA_Drug_Info
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367
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...
SBIA LinkedIn - LinkedIn: cder-small-business-and-industry-assistance
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter - Twitter: FDA_Drug_Info
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367
2 سال پیش
در تاریخ 1401/09/29 منتشر شده
است.
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