Deploying Modeling & Simulation to Enable Advanced Process Monitoring & Control

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Presented by

Johannes Scheiblauer at Takeda and Sean Bermingham at Siemens

About this talk

Presented by Johannes Scheiblauer, Associate Scientific Fellow for Digital CMC at Takeda and Sean Bermingham, Head of Formulated Products at Siemens Several enabling technologies change the way we do pharmaceutical development: automation & digitalization, advanced analytical methods, modeling & simulation. But especially the latter are not silver bullets, and it is important to have a closer look why and when one might use them. In this presentation, we focus on the real-time applications of modeling & simulation in the context of process monitoring & control: how to leverage the underlying technologies to better visualize current process data, improve process control decisions and anticipate future process trajectories. We discuss factors and prerequisites supporting a successful and sustainable implementation, from the “digital maturity” of the processes over the necessary technical building blocks (like robotics & high-throughput experimentation) to aspects of people mindset and change management: what it means for an organization to embrace these new ways of work. Link that was mentioned by Sean Bermingham: https://www.siemens.com/global/en/products/automation/industry-software/gproms-digital-process-design-and-operations/training-and-knowledge-transfer.html Link that was mentioned by Johannes Scheiblauer: https://www.fda.gov/media/165743/download
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