返回 Agenda
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)
Martin Gadsby
Owner & Director, Optimal Industrial Automation Ltd, United Kingdom
Ensuring Regulatory Compliance and Data Integrity with Big Data for Your PAT System Whilst Also Providing Knowledge Management & Closed Loop Control
Jeff Gardner
President & Principal Consultant, DataPharm SDMS, LLC, United States
Developing an Economically Sustainable Control Strategy - How to Use Statistics More Responsibly
Eric Rozet, PHD
Director Statistics, Arlenda S.A., Belgium
Smart Processes Optimization and Control Using Bayesian Predictive Modeling