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2022 ISPE Annual Meeting & Expo

SES104b - Executing an Integrated EPCMV Project at Project Warp Speed – Case Study


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


Description

During this case study, the presenters will take the audience through a complicated, schedule driven project that was chartered by BARDA under the Project Warp Speed program during the height of the Covid-19 pandemic. The primary challenge was to design, build and qualify an integrated Aseptic Isolated Filling Line and ancillary support areas into an existing shell space in an active manufacturing facility in time to deliver critical Covid vaccines to the market place. This forced the entire project team from owner stakeholders to the CQV team to Quality Assurance to work seamlessly and ensure the appropriate controls were in place throughout the process to deliver a functional and compliant line. The team consistently applied the applicable good engineering practices and risk management throughout the process in a streamlined manner to design, build and qualify this facility in record time. We will walk the audience through the specification, design, construction management, commissioning and qualification and risk assessments, while focusing on lessons learned and applicability of the GEP guide to the process.

Speaker(s):

  • Peter Dayrell, Global Director, Project Delivery, Emergent Solutions
  • Paul F. Valerio, Director of Process Technology / Senior Associate, IPS - Integrated Project Services, LLC

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