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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

Description

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.

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