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Understanding FDA’s CSA Guidance in the Context of Current Regulations and GAMP® | 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on understanding CSV and CSA in the context of current regulations and GAMP, the implications, and opportunities of CSA draft guidance on 21 CFR Part 11 and gain the confidence to transition from CSV to CSA and achieve transformative value vs. incremental value.
Speaker(s):
Mr. Khaled
Moussally,
Executive Vice President Clients & Regulatory Relations,
Compliance Group Inc
Ken
Shitamoto,
Executive Director, IT - Quality and Compliance,
Gilead Sciences
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