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Comprehensive Control Strategy: Building Confidence in Quality
Session Chair(s)
John Groskoph, MBA
Executive Director, Global CMC
Pfizer Inc, United States
This forum will present and facilitate discussion on the concept of control strategy and its preeminence in conveying confidence in quality. In particular, the session will highlight various control strategy approaches and their relevance for the patient, regulators, and industry.
Learning Objective : Identify the seminal importance of the concept of control strategy including its role in providing confidence in quality for the patient, regulators and industry; Demonstrate how the adoption of a comprehensive control strategy can improve efficiencies of processes and increase the quality of both chemistry review and drug manufacturing activities.
Speaker(s)
Panelist
John Lepore, PhD
Merck & Co. Inc., United States
QbD and CMC Practices Lead, Global Pharmaceutical Commercialization
Panelist
Christine Moore, PhD
Organon & Co., United States
Executive Director, Global External Advocacy and Standards
Panelist
Sherry Guo, PhD
F. Hoffmann-La Roche Ltd, United States
Head, Global MMTech Analytical Chemistry and Life Cycle Management, Biologics Q
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