473022 Panel Discussion: Current Issues and Challenges for CQA Monitoring and Control for Drug Substance Manufacturing

Wednesday, November 16, 2016: 2:30 PM
Continental 4 (Hilton San Francisco Union Square)
Naiqi Ya, OPQ OPF, FDA CDER, Silver Spring, MD

In this panel discussion, all of the speakers in this session and invited FDA leaders will join for an interactive Q& A session. It will highlight current issues and challenges in the CQA monitoring and control for drug substance manufacturing, from development, manufacturing, to regulatory review and inspection, and life cycle management.

Extended Abstract: File Not Uploaded