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2020 ISPE Annual Meeting & Expo

NA20CENOV1/SES211 - Worldwide State of Quality-Findings from Assessing 1000+ Sites

Nov 4, 2020 1:00pm ‐ Nov 4, 2020 2:30pm

Expiration Date: Nov 30, 2021


Worldwide State of Quality-Findings from Assessing 1000+ Sites | St.Gallen is currently executing the FDA funded project "Quality Benchmarking Study" together with Dun & Bradstreet. In this research project, a shortened OPEX & Quality benchmarking has been developed. it contains a scientifically derived subset of the legacy full St.Gallen Benchmarking and selected Enablers, that have been proven as most meaningful for surrogating overall system’s stability and performance. The assessment is currently conducted in the pharmaceutical industry and will allow access to operational data of 1000+ drug manufacturing sites worldwide. The session starts describing the process of scientifically conceptualizing an assessment that requires a limited set of datapoints but is still meaningful to surrogate overall production & quality system's performance. Afterwards, results from investigating sites worldwide are presented. The session concludes with enhanced analytics on the gathered data, highlighting differences in the level of quality performance across technologies, site types and locations. Relations between certain quality KPIs as well as enablers and the overall state of quality are shown. 1. Scientific methodology to derive an OPEX & quality assessment. 2. Most meaningful quality metrics to assess the production & quality system. 3. Current state of quality performance across different site types, locations & technology platforms.

Session Leader(s):

  • Thomas Friedli, PhD, Professor of Production Management, Director ITEM, Division Production Managemen, University of St. Gallen (Switzerland)


  • Mark Seiss, Director, Advanced Analytic Services, Dunn & Bradstreet Inc.
  • Marten Ritz, Research Associate & Head of Operational Excellence, University of St.Gallen

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