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Operational Excellence - A Foundation for Quality (Session 207)

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Monday 7 November 13.30 – 17.00

ISPE CEUs: 0.35

In the pharmaceutical space, as in any other industry, operational excellence is a long term and continuous effort. Success is contingent on recognizing that the manufacturing process is not only dependant on people but that they are the main driving force of this process. At the same time the current capabilities of automation technology and information systems provide a vital ingredient in enabling operational excellence, and should not be overlooked.

Last year’s interactive operational excellence program at the ISPE annual meeting included a cross functional group of 50+ industry leaders that collectively concluded that "Process Understanding" was a significant gap in their companies and organizations. Recent FDA guidance documents reference the use of operational excellence as the method to drive a Risk Based Approach that is inherently dependant on Process Understanding. This is the challenge that we are taking upon us in order to sustain our businesses and evolve our manufacturing organizations. What are you and the people in your company doing to achieve Operational Excellence as the foundation for quality and growth?

Leaders

Speakers

  • Jeff Campie, USA
  • Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
  • Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
  • Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
  • Edwin Melendez, Principle Consultant, Parexel, USA
  • Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
  • Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
  • Julian Wilkins, Vice President, PharmaConsult US Inc, USA
  • Paul Wreglesworth, Independent Consultant, United Kingdom

How You Will Benefit

  • Set goals of business process mapping

Who Should Attend

Management

Communities of Practice (COPs)

This session is of particular interest to existing and future members of the following ISPE Communities of Practice (COPs):

API, Biotech, GAMP, PAT, and Product Process Development