Category: CSV/CSA

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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 […]

Presented By: Joanne Goldberg, Senior Principal Quality Systems Specialist, Global IT Quality & Compliance, Medtronic

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Presented By:Kim Huynh-Ba, MS, PMP, FAAPS, Managing Director; Adjunct Faculty, Pharmalytik Consulting; RAQA, Temple University

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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 extent of […]

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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 HealthIn 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 frictionless”, where […]

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