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2020 ISPE Annual Meeting & Expo


SES307 - The Future of Facility Build-Outs: Innovations in QA and Electronic Validation


Nov 5, 2020 2:00pm ‐ Nov 5, 2020 3:30pm

Description

Electronic validation (E-Val) is a highly desired capability for many startup and existing pharma and biotech companies. This session leverages experiences and lessons learned from the implementation of Kneat E-Val software during the build-out of ElevateBio’s novel cell and gene therapy facility. Industry professionals will present the audience with insights into the efficiency and programmatic improvements that were created by using Kneat. This includes how the ElevateBio Kneat implementation team worked with different departments to create a harmonized and efficient site-wide CQV program; what additional collaboration was required to ensure that the software and other digital platforms functioned appropriately for the supporting operational systems that were being created in parallel; and the major challenges involved with establishing a culture of innovation across multiple departments to embrace this novel technology.

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