Application Manufacturing Assessment Quality - Oct. 16-17, 2019

Application Manufacturing Assessment (4of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Quality Assessment of BLAs, NDAs, and ANDAs (3of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Case Studies: Continuous Manufacturing of Drug Substance (21of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Pharmaceutical Quality Surveillance Program (14of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

FDA Perspectives on Biosimilar BLA-Manufacturing (28of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Continuous Manufacturing of Drug Product (20of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Change Management: ICH Q12 and Established Conditions (12of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

FDA’s Quality Assessment and Knowledge Management - KASA (11of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

End-to-end Integrated Continuous Manufacturing (25of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Quality-Related Compliance Actions and Trends (15of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Integration of Assessment and Inspection for Biological Products (9of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Policy Considerations for Continuous Manufacturing (19of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Keynote: CDER’s Commitment to Pharmaceutical Quality (1of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Panel Questions and Discussion (6of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Small Molecule Case Studies (8of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Quality Metrics, Quality Culture, and Data-Driven Decisions (16of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Panel Questions and Discussion (22of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Emerging Technology Program (18of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

FDA Research Supporting Emerging Technologies with Case Studies (24of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Panel Questions and Discussion (33of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration