Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017
54:28
Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017
1:22:14
Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs
1:19:35
Chemistry, Manufacturing, and Controls (CMC) for an IND (7of14) REdI 2018
1:10:48
CMC - NDA requirements and Common Pitfalls of BLAs (14of15) REdI – May 29-30, 2019
57:58
Common CMC (Quality) Issues and How to Avoid Them Part I (12of16) Generic Drugs Forum
27:10
Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA - REdI 2020
56:31
CMC Considerations for Biotechnology Product Development: A Regulatory Perspective
1:00:00