Category: CSV/CSA

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The Impact of AI on the GxP Landscape

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 in […]

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Understanding the Implications and Opportunities of CSA Draft Guidance on 21 CFR Part 11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

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Lean Validation Case Study – Build a Modern, Risk-based CSV Program Aligning with CSA and Part 11

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• […]

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Scripted vs. Unscripted Testing – Requirements and Criticality Assessments

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 […]

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Going Paperless Case Study: Understand the Value and ROI of Digitization Platforms

Presented By: Geetanjali Abbi, Director, Digital Quality Assurance, AlkermesThis case study is intended to walk the audience through the transformative journey that Alkermes has been through since our initial transition to ValGenesis 7+ years ago. This will include a discussion on how ValGenesis helped us sustain the workload during the pandemic, lessons learned (both positive […]

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