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2022 ISPE Annual Meeting & Expo

SES201a - Greenfield Operational Readiness via Data Management


Nov 1, 2022 10:45am ‐ Nov 1, 2022 12:15pm


Description

Timely case study of Resilience's flagship viral vector manufacturing facility in Marlborough, MA. This 20 min presentation will focus on the why, the how and results and value using e-validation and go beyond paper on glass and talk about the OR/OE implications of managing data and solutions within one of the major e-validation tools. Charlie Maher, The business process owner for Commissioning, Qualification and Validation and for Operational Readiness across the Resilience network of manufacturing facilities will discuss his vision for digital transformation and how the project embraced e-validation to advance their Pharma 4.0 vision.

Speaker(s):

  • Charlie Maher, BS, MBA, Senior Director, Capital Projects, Validation and Operational Readiness, Resilience
  • Nathan Temple, CQV Business Area Leader, CAI

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