FDA Guidance on Manufacturing During COVID-19 and High Absenteeism
CDER discusses updates regarding policy and approaches toward manufacturing and high absenteeism during the COVID-19 Public Health Emergency (PHE).
Presenters:
CDR Tara Gooen Bizjak
Director
Manufacturing Quality Guidance and Policy Staff| CDER
CDR Emily Thakur, RPh
Team Leader
Drug Shortage Staff | CDER
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/manufacturing-supply-chain-and-inspections-during-covid19-public-health-emergency-08252021-08252021
--------------------
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 FDA Guidance on Manufacturing During COVID-19 and High Absenteeism канала U.S. Food and Drug Administration
Presenters:
CDR Tara Gooen Bizjak
Director
Manufacturing Quality Guidance and Policy Staff| CDER
CDR Emily Thakur, RPh
Team Leader
Drug Shortage Staff | CDER
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/manufacturing-supply-chain-and-inspections-during-covid19-public-health-emergency-08252021-08252021
--------------------
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 FDA Guidance on Manufacturing During COVID-19 and High Absenteeism канала U.S. Food and Drug Administration
Показать
Комментарии отсутствуют
Информация о видео
3 сентября 2021 г. 19:54:45
01:17:23
Другие видео канала
FDA Regulatory Education for Industry (REdI) – Devices TrackPost-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020FDA Drug Topics - FDA Drug Information Resources and Applicability to Health Care ProfessionalsFDA Regulatory Education for Industry (REdI) – Devices and Biologics TrackCellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) Meeting - Day 1Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 1Chemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it.FDA Regulatory Education for Industry (REdI) – Biologics Track2021 FDA Science Forum – Session #1- Improving Clinical and Post-Market EvaluationQuality Management Maturity Program 2022 Public Workshop - Part 1 - Session 1Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 2Quality Management Maturity: FDA Vision & Expectations (8/15) Global QualityIn Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3AQuestions and Answers on Drug Master Files (DMFs) and Drug Substances Part IStakeholder Call - Guillain-Barré Syndrome (GBS), COVID-19 Vaccine Updates - 7/15/21CMC - NDA requirements and Common Pitfalls of BLAs (14of15) REdI – May 29-30, 2019Vaccines and Related Biological Products Advisory Committee – 6/7/2022Introduction to the FDA Office of Training, Education, and Development’s Train-the-Trainer ProgramFDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene TherapyHow Can I Become a Qualified Instructor for an OTED Course?