Next Meeting: Pharmaceutical Control Strategy – what does it mean and how do we apply it?
NJPhast/AAiPS Joint meeting
In pharmaceutical manufacturing there is often confusion over the term control strategy. The view from an automation engineering perspective is often totally different than the view from a product quality/release view point, and often documents meant primarily to help the end user have to include definitions of the terms (for example ICH Q8 (R2). Even within a specific usage of the term there is multiple perspectives, which can lead to further confusion and the need for clarification.
The purpose of this presentation is to give an overview of the world of control strategy, try to illustrate where some of the opposing viewpoints come from but also to do a deeper dive into the most common implementations of pharmaceutical control strategy, using the FDA complexity pyramid to help explain not only what pharmaceutical Control Strategy means, but more so how it can be differently applied (both even batch and continuous manufacturing) and also, to try and take a look into the future and suggest how pharmaceutical control will be impacted/changed by activities such as advanced manufacturing/Industry4.0.
About the speaker
Martin is Director of Martin Warman Consultancy Ltd, providing services to support PAT enabled Control Strategies for both batch and continuous manufacturing (CM).
Previously he spent 7 years as a Scientific Fellow II at Vertex Pharmaceuticals supporting the use of PAT within a QbD framework, from process development to enabling Control Strategies for real time release. This includes a special focus on CM and process innovation, and he was one of the co-leads of the Vertex Scale-up and Process Innovation Team (SUPIT) responsible for developing the Vertex DLR platform on which the first approved CM process runs.
He has over 25 years’ experience in the field having worked in the pharmaceutical (incl. 14 years leading the Global PAT Development Team Pfizer, GMS), the instrument sector (with Dionex), in petrochemical (Shell) and in academia (University of Westminster).
Martin is also on the Executive Committee of ASTM E55 covering Pharmaceutical Manufacturing, and chairs the E55.01 sub-committee covering PAT and Risk Management. He also and sits on the ISPE PAT & LCS Community of Practice (CoP) global steering committee, and chairs the UK Affiliate PAT & LCS CoP steering committee.
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