API Manufacturing Global Distribution and Facility Profile Analysis
Submit proposed questions on this poster to DMFWorkshop2021@fda.hhs.gov by March 19, 2021, and tune in for the subsequent panel discussion during the Drug Master File (DMF) and Drug Substance follow-up webinar on April 9, 2021.
To review posters and register for the webinar, visit: https://www.fda.gov/drugs/news-events-human-drugs/drug-master-file-dmf-and-drug-substance-question-and-answer-webinar-following-march-3-4-2021
This poster discusses the diverse and complex global API supply chain.
To view all posters and conference presentations, visit: https://www.fda.gov/drugs/news-events-human-drugs/drug-master-file-dmf-and-drug-substance-workshop-03032021-03042021
To listen to a Q&A on poster and conference topics, visit: https://www.fda.gov/drugs/news-events-human-drugs/drug-master-file-dmf-and-drug-substance-question-and-answer-webinar-following-march-3-4-2021
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 2021 Playlist - https://youtube.com/playlist?list=PLey4Qe-UxcxYS1MaTusSgyifQDqdeepyD
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
Видео API Manufacturing Global Distribution and Facility Profile Analysis канала U.S. Food and Drug Administration
To review posters and register for the webinar, visit: https://www.fda.gov/drugs/news-events-human-drugs/drug-master-file-dmf-and-drug-substance-question-and-answer-webinar-following-march-3-4-2021
This poster discusses the diverse and complex global API supply chain.
To view all posters and conference presentations, visit: https://www.fda.gov/drugs/news-events-human-drugs/drug-master-file-dmf-and-drug-substance-workshop-03032021-03042021
To listen to a Q&A on poster and conference topics, visit: https://www.fda.gov/drugs/news-events-human-drugs/drug-master-file-dmf-and-drug-substance-question-and-answer-webinar-following-march-3-4-2021
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 2021 Playlist - https://youtube.com/playlist?list=PLey4Qe-UxcxYS1MaTusSgyifQDqdeepyD
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
Видео API Manufacturing Global Distribution and Facility Profile Analysis канала U.S. Food and Drug Administration
Показать
Комментарии отсутствуют
Информация о видео
2 февраля 2021 г. 19:21:56
00:17:09
Другие видео канала
Natural History Studies for Rare DiseasesFDA Safety Report Type Flag Requirement for FAERS SubmissionsOriginal TYPE V VMF Section 9.0 Depyrogenation Walk ThroughOriginal TYPE V VMF Section 4.0 Sterilization In Place Walk ThroughOriginal TYPE V VMF Section 1.0 General Information Walk ThroughOriginal TYPE V VMF Section 11.0 Media Fills Walk ThroughOriginal TYPE V VMF Section 2.0 Product Information Walk ThroughCellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) Meeting - Day 1Original TYPE V VMF Section 3.0 Buildings and Facilities Walk ThroughPromotional Submissions in eCTD Format - Grouped SubmissionsCellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) Meeting - Day 2FDA Guidance on Manufacturing During COVID-19 and High AbsenteeismVaccines and Related Biological Products Advisory Committee - 12/17/2020Risk Management and Application Approaches in Responding to Supply Chain Constraints During PHEInspections and Use of Alternate Tools During the COVID-19 Public Health Emergency + Q/A PanelOriginal TYPE V VMF Section 6.0 Sterilization of Components Equipment by Irradiation Walk ThroughOriginal TYPE V VMF Section 8.0 Terminal Sterilization by Irradiation Walk ThroughOriginal TYPE V VMF Section 10.0 Environmental Monitoring Walk ThroughOriginal TYPE V VMF Section 7.0 Terminal Sterilization by Moist Steam Walk ThroughCOVID-19 Vaccines: Safety and Diversity