Facility Evaluation And Inspection Generic Drugs Forum 2017

Facility Evaluation and Inspection (26/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

Keynote – Office of Pharmaceutical Quality (2/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

OPQ Integrated Quality Assessment (IQA) Process (20/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

Integrated Process and Facilities Assessment (26of27) Generic Drugs Forum 2018

U.S. Food and Drug Administration

Filing Review – Do’s and Don’ts (14/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

Generic Drug Product Quality Review (23/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

ICH Q12 Guidance and Emerging Technology Program (11of16) Generic Drugs Forum 2020

U.S. Food and Drug Administration

Office of Pharmaceutical Quality Policy Update (4/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

Deficiencies and Observations from Facility Evaluations and Inspections(27of28) GDF – Apr. 3-4, 2019

U.S. Food and Drug Administration

Introduction to “The ANDA Review Pathway” (11/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

ANDA Performance/Operations Update (3/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

GDUFA II (9/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

Keynote – Office of Generic Drugs (1/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

Development of Single, Shared System REMS (10/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

GDUFA Regulatory Science Research Update (5/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

Manufacturing Process and Controls (25/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

Panel Discussion (8/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

Preparing for GDUFA II User Fees (6/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

Panel Discussion (19/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

Pharmaceutical Quality Update by Dr. Michael Kopcha (2of27) Generic Drugs Forum April 2018

U.S. Food and Drug Administration