This session will concentrate on implementing CSA that will provide guidance and resources to support it. The content will focus on understanding CSV and CSA in the context of current regulations and GAMP, the implications, and opportunities of CSA draft guidance on 21 CFR Part 11 and gain the confidence to transition from CSV to CSA and achieve transformative value vs. incremental value.
Speakers:
Khaled Moussally
Executive VP Quality – Clients & Regulatory Relations at Compliance Group Inc
Ken Shitamoto
Executive Director, IT Quality and Compliance at Gilead Sciences