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2020 ISPE Annual Meeting & Expo


SES308 - Quality 4.0


Nov 5, 2020 2:00pm ‐ Nov 5, 2020 3:30pm

Description

Digitalization has reached the Pharmaceutical Industry. The ability to leverage the potential of data to master processes and products as differentiator has been understood. The transformation from a classical documentation-based, functionally segregated towards a data-driven, end-to-end integrated production and quality management is one major objective towards the Pharma 4.0. The Holistic Control Strategy and Digital SOPs are enabler and accelerator for Pharma 4.0.
The panel/roundtable session will start with 2 short presentations:
1. "ISPE Pharma 4.0 Holistic Control Strategy Model", Christian Woelbeling
2. “The SOP of Future – the right information at the right time”, Heike Roeder
about the principles of HCS and Digital SOP and how the world might look like under the assumption of full digital implementation. This presentation will include a short mock-up of integration of digital SOPs into a shop floor execution system, in this case manufacturing Execution System/MES.
Followed by a discussion of the audience and/or participants of the panel/roundtable with regards to the following questions (and further questions coming from the audience):
• What kind of initiatives do you run to improve/transform you product supply and/or SOP Management towards digitalization?
• What are the benefits you are expecting?
• What are the risks?

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