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, […]

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• […]

Presented by: Marc Koetter, Senior Manager Computer System Validation & IT Governance, Fresenius Medical Care• Understand the difference between scripted and unscripted testing• Identify variants of unscripted testing• Lear how to minimize test documentation burden whilst gaining maximum test coverage by using unscripted testing• Understand the compliance of unscripted testing with the regulations• Learn when […]