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Automated System Testing: Driving Process Performance and Data Integrity Part 2 (Session 407)

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Tuesday 8 November 14:15 – 17.15

ISPE CEUs: 0.25

Too much testing is a waste of valuable resources. Insufficient testing can have catastrophic consequences and may not ensure product quality nor data integrity, thereby increasing the risk to the patient. This session will illustrate how risk based testing is an essential element in assuring process performance and data integrity. Using a combination of presentations, case studies and interactive workshops, it will be demonstrated how computerized systems employed throughout manufacturing and product release processes are verified and tested using innovative methods and technologies following a risk based approach.

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

  • Understand effective risk-based approaches to verification and testing
  • Understand key accountabilities and roles engaged in testing
  • Realize where current methodologies and tools are utilized to support effective risk based testing
  • Update your knowledge with respect to current Good Testing Practices and application to different technologies

Who Should Attend

Test Managers and Test Teams, Project Managers, Q&A Managers and Q&A personnel, Validation personnel and Suppliers

Communities of Practice (COPs)

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

Critical Utilities, GAMP, Commissioning and Qualification, and Project Management