Understanding the Implications and Opportunities of CSA Draft Guidance on 21 CFR Part 11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. FDASince the release of the FDA draft on Computer Software Assurance (CSA), September 13th, […]

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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. FDASince the release of the FDA draft on Computer Software Assurance (CSA), September 13th, […]

To access this post, you must purchase MEMBER PLUS + or MEMBER PLUS 6M FREE.

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