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2022 ISPE Annual Meeting & Expo

SES104 - Concurrent Session: GPG Good Engineering Practices


Oct 31, 2022 11:00am ‐ Oct 31, 2022 12:30pm


Description

The COVID pandemic, and more specifically, Operation Warp Speed driven projects, rocked the global supply chain and taught the industry that the paradigm of typical project durations could be shattered. The success of a number of these projects has driven the industry to expect an unprecedented level of speed on future projects. Good Engineering Practices are critical to the delivery of compliant biopharmaceutical projects; however, their application is absolutely crucial as design, procurement and verification activities are conducted throughout fast-tracked projects. This session will describe the concepts of the guide, the principles and drivers behind its revision, and the practical application of the guide for customers’ use. In addition, speakers will provide a case study of a BARDA funded Operation Warp Speed BSL-2 Aseptic / Isolated Formulation and Filling Facility with a project duration of 11 months from concept to aseptic process simulation readiness, which completely challenged the paradigm and basic understanding of how fast a project would be delivered from concept through CQV.

Speaker(s):

  • Michael Westerman, Vice President, CQV Operations, IPS - Integrated Project Services, LLC

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