Category: Conference Sessions

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Understanding the Implications and Opportunities of CSA Draft Guidance on 21 CFR Part 11

Presented by:Stephen Cook, Sr. Director – Governance & Operational Excellence, GSK Louie Rayal, Vice President, Governance, Risk and Compliance, GSK Marc Koetter, Senior Manager Computer System Validation & IT Governance, Fresenius Medical Care Cisco Vicenty, Case for Quality Program Manager, U.S. FDA Since the release of the FDA draft on Computer Software Assurance (CSA), September […]

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