Category: CSV/CSA

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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 & […]

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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 […]

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

Presented By: Geetanjali Abbi, Director, Digital Quality Assurance, Alkermes This 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 […]

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Superintelligence Governance: Advancements vs. Ethics – How to Safely Use Advanced Technologies and Avoid a Catastrophe

Presented By: Steve Thompson, Senior Director Product Marketing, ValGenesis • Recent technology advancements that are promising and problematic? • Learning from our past mistakes – How catastrophes became the catalyst for regulatory action • Assessing our current risk management process(es) • Establishing governance for advanced technologies • Knowing who’s ultimately responsible, and how to protect […]

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  • Phone: 858 649 3251
  • Email: info@kenx.org
  • Phone: 858 649 3251
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