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Created by: Jacob Hodovsky, Computer Systems Validation and Project Manager, CAIDay-3-1045am_Jacob-Hodovsky_DI-Assessment-Tool-Workshop-HandoutDownload
Created by: Mehron Mirian, Director of Automation Services, VTI Life Sciences Day-2-415pm_Mehron-Mirian_-Handout-GAMP5checklistR0-3Download
Presented by:Stephen Cook, Sr. Director – Governance & Operational Excellence, GSKLouie 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, 2022, […]
Presented by:Calvin Kim, Head of Quality Systems and Validation, Samsung Biologics Suju Hwang, Senior Manager, Digital Quality & Compliance, Samsung Biologics• Gain insight on how key strategy & framework are established in consideration of risk-based approach in CSA and Part 11 requirements• Understand the importance of aligning R&R across CSV relevant processes & stakeholders• Determine […]
