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The first presentation of the session will provide insights into digitization trends within MSAT, best practices and potential pitfalls. The presentation will provide specific examples and use cases of digitization and the implementation of PAT in the manufacturing environment.
The second part of the Process Analytical Technology session will discuss best practices in the design, implementation, and operation of PAT for actual GMP operations. The design and implementation drives the digital transformation. This includes the IT infrastructure requirements to facilitate the data management under GMP standards, the application of 'classical' PAT based on spectroscopic equipment through to soft sensors i.e., data-driven analytics, and process insights revealed by PAT back to the control strategy as a holistic instrument.
1530 – 1600: PAT as part of the digital evolution in MSAT Use cases by Veronika Nindl 1600 – 1650: Application of PAT for Real-World GMP Operations by Dr. Hubertus Rehbaum, Line Lundsberg-Nielsen and Andrew Palm 1650 – 1700: Question and Answer/Panel Discussion moderated by Robert Perks
Session Leader(s):
Robert
E. Perks,
MSc, CEng,
Senior Director, Business Development,
PQE US Inc.
Speaker(s):
Andrew
Palm,
Director, Integrated Process Analytics,
Pfizer
Hubertus
Rehbaum,
Managing Director,
Dr. Rehbaum Technology Consulting GmbH