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 InternationalPart 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 lifecycle […]
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 […]
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 […]
Presented by: Linda Lagrou, Senior Manager IT Quality, Abbott LaboratoriesGaurav Walia, Senior Global Director and Sr. Associate Partner, PQE Group • Demonstration of CSA practical execution• Real world highlights of CSA implementation case study• Use of critical thinking with the implementation• Use of automation tools with the CSA Approach• Overarching […]
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