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Session Leader Michael Westerman Vice President, CQV Operations along with speakers Paul Valerio Director of Process Technology/Senior Associate at IPS-Integrated Project Services, Peter Dayrell Global Director, Project Delivery at Emergent Solutions, and Chip Bennett, PMP Associate Director, Global C&Q at CAI discuss how important 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.

For session information on this session see the ISPE agenda.

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