CSV/CSA Archives - Kenx Members

Category: CSV/CSA

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How to Enable Validation/Pharma 4.0 Through Digital Validation and Emerging Technologies

Presented by: Philip Jarvis, Director Integrated C&Q and Paperless Strategy, Veqtor Solutions Discussion on how emerging technology such as AI/and machine learning has the potential to change the world of validation , and help achieve validation 4.0 principles . How do we create a digital validation ecosystem ,create data integrity by design, and harness digital […]

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Qualification/Validation Of Cloud Services & External Facing Applications

Presented by: Pranita Barve, Validation Lead, ZS Princeton, NJLaurent Saugrin, Associate Director Computer Software Assurance, CAI Vinodh Rodrigues, VP, Customer Success, Quartic.ai

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What’s Stopping You? Overcoming CSA Adoption Concerns

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 […]

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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 […]

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Understanding the Implications and Opportunities of CSA Draft Guidance on 21 CFR Part 11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

Category: CSV/CSA

How to Enable Validation/Pharma 4.0 Through Digital Validation and Emerging Technologies

Qualification/Validation Of Cloud Services & External Facing Applications

What’s Stopping You? Overcoming CSA Adoption Concerns

The Impact of AI on the GxP Landscape

Understanding the Implications and Opportunities of CSA Draft Guidance on 21 CFR Part 11

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Digital CQV and Pharma 4.0: Paving the Way for Future Success

Automating Digital Validation

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