Presented By: LeAnna Pearson, Associate Director Quality Compliance & Regulatory, CAI Part 1 – CAPA 101 back to basics• Understand the purpose and history behind the CAPA• Understand what the FDA is expecting from your CAPA• Understand when to use a CAPA• Review the typical CAPA processPart 2 – Building blocks of an effective CAPA […]
Presented By:Kim Huynh-Ba, MS, PMP, FAAPS, Managing Director; Adjunct Faculty, Pharmalytik Consulting; RAQA, Temple University
Presented By:Pedro Ferreira, Quality Risk Management Tech Lead, ValGenesis Margarida Ventura, Quality Risk Management Consulting Lead, ValGenesis Dr. Iris Ziegler, Director Pharmaceutical Sciences and QbD, Corden Pharma International Part 1 – Commercial and Lifecycle Implementations of Quality Risk Management• Draw a baseline on what QRM is in terms of goals and context• Understand the QRM […]
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 […]
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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