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Inaugural Conference on Quality Culture and Quality Metrics

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ISPE announced its inaugural Conference on Quality Culture and Quality Metrics, taking place 25 – 26 April in Bethesda, Maryland USA. This uniquely focused event will feature high-level sessions, aligned with the FDA’s revised draft guidance on quality metrics and ISPE’s on-going Quality Culture and Quality Metrics Initiatives. In-depth workshops will provide insights on the Six Dimensions Framework in the Cultural Excellence report.

Sustainable production of high quality, available products demand a knowledgeable and devoted mindset to improve quality culture,” said John Bournas, ISPE CEO and President. “This conference was crafted to provide an enriched understanding of how quality metrics and quality culture are used throughout the pharmaceutical industry to monitor quality management systems and processes, and drive continuous improvement efforts in drug manufacturing.

The ISPE Conference on Quality Culture and Quality Metrics will feature a collection of practical, powerful tools and a comprehensive, behavior-based approach for improving quality culture as a means of delivering enhanced quality outcomes. This event will also deliver the latest data and insights for operationalization of quality metrics across the supply chain.

Keynote speakers include:

  • Mark Birse – Group Manager Inspectorate, Inspection, Enforcement & Standards Division, MHRA
  • Shane Yount – Chief Operating Officer, Principal, Competitive Solutions, Inc.
  • Lawrence Yu, PhD – Deputy Director, FDA/CDER/OPQ (Invited)
  • Louis Yu, PhD – Chief Quality Officer, Valeant Pharmaceuticals International, Inc.

There will also be a high-level industry panel on quality culture, and special sessions on quality metrics with industry leaders and three FDA experts.