Duration: (4:32) ?Subscribe5835 2025-02-09T15:03:38+00:00
DMF section 3.2.S.4 - Control of drug substance
(4:32)
List of Relevant Quality Guidances \u0026 Common Deficiencies Observed during DMF Review
(10:57)
What is a DMF (drug master file)?
(5:40)
DMF section 3.2.S.3 - Characterization
(6:20)
DMF section 3.2.S.1 - General information
(4:2)
DMF section 3.2.S.2 - Manufacture
(4:41)
DMF section 3.2.S.7 - Stability
(6:55)
What the DMF!: Spotlight on Forge's Drug Master File
(3:22)
Introduction to the Drug Master File (DMF) Review Process
(24:28)
Tips to Streamlining the Drug Master File Process
(59:36)
Major Issues and Facilities in Drug Master Files (9/15) Global Quality
(20:6)
DMF section 3.2.S.5 - Reference standards
(2:23)
Drug Substance Facilities – Hidden and Critical Intermediate
(24:59)
DMF - Drug Master File l Drug Substance Application to FDA l API l Active Pharmaceutical Ingredient
(5:13)
Panel Discussion - Drug Master File and Drug Substance Workshop
(24:23)
Managing Electronic Drug Master File Submissions
(26:25)
Review of Secondary Type II Drug Master Files
(15:3)
Panel Discussion - Drug Master File (DMF) and Drug Substance Workshop
(18:11)