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Quality Management Post-Quality Management System Implementation In The Wake of ICH E6 (R2)
Session Chair(s)
Jay A Turpen
Head, Quality Assurance
Diligent Pharma LLC, United States
The key characteristics of a QMS with a focus on how the size of an organization impacts the QMS characteristics and their risk-based methodologies, including what key learnings organizations of varying sizes can learn from each other’s experiences.
Learning Objective : Discuss the differing characteristics of a QMS based on the size of the organization; Compare how these characteristics changed in preparation for ICH E6 R2 implementation; Determine whether risk-based approaches vary based on organizational size and what organizations of different sizes can learn from each other.
Speaker(s)
Assessing Your Clinical Quality Management System: A Comprehensive Review of TransCelerate’s CQMS Assessment Tool
Michael Husovich
Amgen Inc., United States
Director, Global R&D Quality
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Lenna Kimball, MBA
Lyell Immunopharma, Inc., United States
Vice President, Clinical Operations
Panelist
RJ Doornbos, RPH
Bristol-Myers Squibb Company, United States
Head of Global Quality Systems, Global Quality