Possible roles of A-TEEM during development and operation of a product perfromance control strategy

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 a control strategy is developed and then implemented and the role of played by novel technologies, using A-TEEM as an exemplar, showing its use from a product development lab bench through to process control but also the potential for automated parallel/confirmation testings