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2021 ISPE Annual Meeting & Expo

Concurrent Session: Elements of Digitalization in the Pharma 4.0 Journey

Nov 2, 2021 2:00pm ‐ Nov 2, 2021 3:30pm


Concurrent Session: Elements of Digitalization in the Pharma 4.0 Journey|The session will examine the components required as the industry progresses towards an implementation of the Pharma 4.0 concept where manufacturing is driven by the digitization of processes and methodologies.  The speakers will explore various aspects required in the realization of a Pharma 4.0 enabled facility including the building of digital solutions in a GMP environment, the digitization of SOPs, the elimination of paper and data capture to produce a digital batch record.  We will hear a case study that provides insight into the delivery of data as a validation package and the benefits that will transform the validation efforts moving forward.  Within the context of Pharma 4.0 we will also review the function of the operator in this new environment and how their role will change from one of system monitoring to the role of contributor and collaborator and the tools required to achieve this paradigm shift.

Session Leader(s):

  • Robert E. Perks, MSc, CEng, Regional Manager, Cognizant Life Sciences Manufacturing


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