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 yourself and your companyTakeaway Tools• […]
Presented By: Joanne Goldberg, Senior Principal Quality Systems Specialist, Global IT Quality & Compliance, Medtronic
Presented By: LeAnna Pearson, Associate Director Quality Compliance & Regulatory, CAIPart 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 Strategy• […]
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 […]
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