视频选集 D1S01 Drug Master File (DMF) and Drug Substance Workshop D1S02 Introduction to the Drug Master File (DMF) Review Process D1S03 Administrative Aspects of Managing a Drug Master File (DMF) D1S05 Managing Electronic Drug Master File Submissions D1S06 Drug Master Files from a GDUFA II User Fee Perspective D1S07 Timely Consult and Early Information Request (TCIR) Process for Drug Mas D1S08 Effective Communication Strategies for Drug Master Files (DMF) D1S10-Day-1-Posters - Drug Master File (DMF) and Drug Substance Workshop D1S11 Drug Substance Facilities – Hidden and Critical Intermediate D1S12 A Supporting Document for the Selection and Justification of Starting Mat D1S14 Common Issues Related to LC and GC Methods in Type II DMFs D1S15 Process Validation and ICH Q7 D1S16 Regulatory Considerations in Demonstrating Complex API Sameness Panel Discussion - Drug Master File (DMF) and Drug Substance Workshop Panel Discussion – Drug Master File and Drug Substance Workshop_2 Panel Discussion – Drug Master File and Drug Substance Workshop_3
