Category: CSV/CSA

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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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Software Fundamentals – Writing Test Scripts to Support CSA

Presented by: Vignesh Srinivas, Service Delivery Manager, Zifo RnD Solutions •    Learn different types of testing – Exploratory, unscripted, and scripted testing•    Understand the difference between Robust test script, Bounded test script (scripted testing) and Unscripted test script (unscripted testing)•    Understand Risk Priority Value and how it is used to determine the […]

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(Panel) CSA – The Foundation for Digital Transformation

Presented by: David DeLuca, Director, Engineering & Validation, Compliance GroupFrancisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDABill Lee, Director of Information Services, DAP Health In an era where digital transformation is pivotal, the Compliance Group (CG) is proud to host a panel discussion uniting industry experts with a shared vision to “make quality […]

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