DIA CMC Workshop

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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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