Understanding FDA Inspections and Data
9.8 هزار بار بازدید -
10 ماه پیش
-
FDA provides an overview of
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...
-----------------------
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
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...
-----------------------
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
10 ماه پیش
در تاریخ 1402/06/28 منتشر شده
است.
9,803
بـار بازدید شده