Category: CSV/CSA

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Project Management – Understanding Your Sphere of Influence

Presented by: Patrick Hayes, Associate Director Program and Project Management, CAI, Inc. & Erik Adams, Associate Director Program and Project Management, CAI, Inc. Top Reasons to Watch:• Define the Sphere of Influence within Project Management• Understand the Importance of working within your Sphere of Influence• Maximizing the Project Managers Sphere of Influence• Understanding Industry Engagement […]

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Compliance Advantages of Moving Towards Paperless Integrated Risk-based CSV

Presented by: Rick Mineo, Director of Strategic Partnerships- Kneat, and Martin Radecki, Sr. Partner and Managing Director- Veqtor Validation experts Rick Mineo and Martin Radecki will go through the different compliance advantages to using paperless validation with integrated risk-based CSV processes. This webinar will cover the tools needed to be successful when taking this approach […]

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The Gartner Hype Cycle & CSA

Presented by – Stefan Muench, Business Director Validation, Körber Pharma Consulting  Key Learning Points: Technology Trigger: FDA’s case for quality initiativePeak of Inflated Expectations: VaporwareTrough of Disillusionment: A ghosting guidanceSlope of Enlightenment: Hide and seek – CSA in G5SEPlateau of Productivity: Reserved for future use Key Takeaways: What are the drivers behind CSA?How CSA permeated […]

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A Tactical Approach to Implementing CSA in Your Organization

Presented by Scott Cady, Senior IT Quality & Compliance Consultant, Azzur Group and Brian Verrico, Senior Computer Systems Validation Consultant, Azzur Group This session focuses on the experienced validator’s new role in the SDLC process. Designed for seasoned Validation and Quality professionals with a general understanding of the CSA concepts (i.e., risk-based approach) and versed […]

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Benefits and Lessons Learned on the Journey to Electronic Validation

Validation experts Derek Hughes, Kneat, and Nathan Temple, CAI discuss the journey to electronic validation. They cover both the benefits and lessons learned during the process and provide helpful insights for industry professionals to start their journey. At the end of this webinar you’ll be able to: Understand the difference between paper-based and digital validationBring […]

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