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Radisson Blu

20 jun 2018 7:45 a.m. - 21 jun 2018 5:00 p.m.

Steinentorstrasse 25, 4001 Basel, Switzerland

DIA CMC Workshop

Session 3B: Enhanced Control Strategy

Session Chair(s)

Elaine  Morefield, PhD, RPh

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

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

Jeff  Gardner

Developing an Economically Sustainable Control Strategy - How to Use Statistics More Responsibly

Jeff Gardner

DataPharm SDMS, LLC, United States

President & Principal Consultant

Eric  Rozet, PhD

Smart Processes Optimization and Control Using Bayesian Predictive Modeling

Eric Rozet, PhD

Arlenda S.A., Belgium

Director Statistics

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