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Session 3B: Enhanced Control Strategy
Session Chair(s)
Elaine Morefield, PhD, RPh
Vice President, Regulatory Affairs
VaxForm, LLC., United States
This session will explore the benefits and challenges of using enhanced control strategies approaches such as using PAT for real time release and using statistical process control. The GMP aspects of advanced control strategy will be discussed. A panel Q&A session will give attendees a chance to participate in the discussion.
Speaker(s)
Ensuring Regulatory Compliance and Data Integrity with Big Data for Your PAT System Whilst Also Providing Knowledge Management & Closed Loop Control
Martin Gadsby
Optimal Industrial Automation Ltd, United Kingdom
Owner & Director
Developing an Economically Sustainable Control Strategy - How to Use Statistics More Responsibly
Jeff Gardner
DataPharm SDMS, LLC, United States
President & Principal Consultant
Smart Processes Optimization and Control Using Bayesian Predictive Modeling
Eric Rozet, PhD
Arlenda S.A., Belgium
Director Statistics
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