Moving the Implementation of Digital Technologies in Pharmaceutical Manufactu..

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Presented by

Thomas O’Connor, Scientist at FDA, Mark Demesmaeker and Chris McCready at Sartorius

About this talk

Full Title: Moving the Implementation of Digital Technologies in Pharmaceutical Manufacturing Forward Presented by Thomas O’Connor, Scientist at FDA Industry 4.0 encompasses a wide range of technologies including industrial internet of things (IIOT), artificial intelligence (AI), and digital twins that have the potential to significantly increase the efficiency and robustness of pharmaceutical manufacturing. The implementation of Industry 4.0 technologies within the context of pharmaceutical manufacturing especially for applications that impact the control of the process or quality decision making may be subject to additional uncertainty in determining how the technologies fits within existing regulatory approaches. The presentation will describe FDA’s manufacturing science research programs that aim to proactively address such regulatory uncertainties. Case studies on the application of digital twins and advanced process control will be highlighted.

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