Good Manufacturing Practices (GMPs) from an IND Perspective (11of14) REdI 2018

  Рет қаралды 5,785

U.S. Food and Drug Administration

U.S. Food and Drug Administration

Күн бұрын

CDER’s Maria Cecilia Tami discusses GMPs pertinent to INDs with an emphasis on the relevant guidances.
_______________________________
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: www.fda.gov/cd...
CDER SBIA 2018 Playlist: • 2018 CDER Small Busine...
LinkedIn: / cder-small-business-an...
Training resources: www.fda.gov/cd...
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.go...
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367

Пікірлер
CDER Small Business and Industry Assistance Overview (12of14) REdI 2018
25:07
U.S. Food and Drug Administration
Рет қаралды 3 М.
Chemistry, Manufacturing, and Controls (CMC) for an IND (7of14) REdI 2018
1:19:35
U.S. Food and Drug Administration
Рет қаралды 28 М.
Human vs Jet Engine
00:19
MrBeast
Рет қаралды 168 МЛН
兔子姐姐最终逃走了吗?#小丑#兔子警官#家庭
00:58
小蚂蚁和小宇宙
Рет қаралды 14 МЛН
小蚂蚁会选到什么呢!#火影忍者 #佐助 #家庭
00:47
火影忍者一家
Рет қаралды 127 МЛН
Миллионер | 2 - серия
16:04
Million Show
Рет қаралды 1,8 МЛН
Quality and Control of Clinical Trial Data (6of11) GCP Data Integrity Workshop
56:11
U.S. Food and Drug Administration
Рет қаралды 4,4 М.
Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6of14) REdI 2018
44:31
October 31, 2024 Endocrinologic and Metabolic Drugs Advisory Committee
U.S. Food and Drug Administration
Рет қаралды 390
Postmarketing Adverse Drug Experience (PADE) Inspections - (1of3) Jun. 19, 2018
1:03:54
U.S. Food and Drug Administration
Рет қаралды 2,7 М.
Office of Pharmaceutical Quality (OPQ) Reorganization Webinar
38:20
U.S. Food and Drug Administration
Рет қаралды 1,9 М.
Electronic Systems, Electronic Records, and Electronic Signatures Webinar
1:25:33
U.S. Food and Drug Administration
Рет қаралды 4,6 М.
Best Practices for Conducting Bioequivalence Studies (16of27) Generic Drugs Forum 2018
30:26
U.S. Food and Drug Administration
Рет қаралды 3,6 М.
Walkthrough of a Pre-Approval Manufacturing Site Inspection (14of14) REdI 2018
44:32
U.S. Food and Drug Administration
Рет қаралды 3,7 М.
FDA Regulatory Requirements for Clinical Investigators and Case Examples (9of14) REdI 2018
41:00
U.S. Food and Drug Administration
Рет қаралды 4,1 М.
Human vs Jet Engine
00:19
MrBeast
Рет қаралды 168 МЛН