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2020 ISPE Annual Meeting & Expo

SES410 - Performance-Based and Advanced Control Strategies

Nov 6, 2020 11:30am ‐ Nov 6, 2020 1:00pm

Expiration Date: Nov 30, 2021


Performance-based control strategies as defined in ICH Q12 and advanced control strategies based on PAT, soft sensors, and other mathematical approaches for controlling and optimizing a pharmaceutical manufacturing process in real-time, is one of the latest opportunities for smart and efficient manufacturing. However, the applications of these control strategies are still in the early days and how to develop, implement, validate and maintain these are a topic that is still not fully understood and is an ongoing discussed between the industry and regulators.
The session we will provide examples of these performance-based control strategies applied for continuous OSD manufacturing and biologic processes and we will discuss advantages, opportunities and challenges in the perspective of life cycle management.

Session Leader(s):


  • Lorenz Liesum, PhD, Head of Advanced Analytical Technologies, F. Hoffmann-La Roche Ltd.
  • Melanie Dumarey, PhD, Product and Process Design Engineer, AstraZeneca
  • Angela Liu, Associate Research Fellow, Pfizer

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