Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020
FDA discusses post approval changes related to manufacturing process and facilities during the continued process verification stage, including modifying the approved manufacturing process, adding or removing a manufacturing line, replacing the current equipment with a new equipment, and changing of manufacturing site/location. Examples are given for each change and FDA shares the appropriate type of submissions (PAS, CBE0, CBE30, or Annual Report) that would be typically expected based on the changes.
Presenter:
Rose Xu, Quality Assessment Lead (Acting)
Office of Pharmaceutical Manufacturing Assessment (OPMA) OPQ | CDER
_______________________________
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 and free continuing education credits: https://www.fda.gov/cdersbia
CDER SBIA 2020 Playlist: https://www.youtube.com/playlist?list=PLey4Qe-UxcxZiTopt4biuIyxmUQJDkaWb
LinkedIn: https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
Training resources: https://www.fda.gov/cderbsbialearn
Twitter: https://twitter.com/FDA_Drug_Info
CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionmanagement
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
Видео Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020 канала U.S. Food and Drug Administration
Presenter:
Rose Xu, Quality Assessment Lead (Acting)
Office of Pharmaceutical Manufacturing Assessment (OPMA) OPQ | CDER
_______________________________
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 and free continuing education credits: https://www.fda.gov/cdersbia
CDER SBIA 2020 Playlist: https://www.youtube.com/playlist?list=PLey4Qe-UxcxZiTopt4biuIyxmUQJDkaWb
LinkedIn: https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
Training resources: https://www.fda.gov/cderbsbialearn
Twitter: https://twitter.com/FDA_Drug_Info
CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionmanagement
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
Видео Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020 канала U.S. Food and Drug Administration
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1 сентября 2020 г. 0:09:57
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