Presented by: Jeff Ramos, Solutions Engineer, ValGenesis Change is the only permanent thing in this world. However, in Life Sciences, adapting to new norms may be slow and can lead to apprehension. Join us in this webinar to learn how you can mitigate those fears and take a path forward to adapt CSA in your […]
Presented by: Rosalind Beasley, CEO and Co-founder, Main and Mission, Inc.Tim Kirkelie, Med Tech Executive / consultant, Main and Mission, Inc. Discover how AI technologies are reshaping the future of compliance, quality control, and data management processes. Gain valuable insights from industry experts and learn how to leverage AI to navigate challenges and drive innovation […]
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 […]
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 & […]
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 […]
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