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Pharma Manufacturer’s C&Q Risk Approach Task Team Forum III - Process and Practices (Session 303)

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Tuesday 8 November 08.15 – 11.30

ISPE CEUs: 0.23

Streamlined commissioning and qualification processes based on Science and Risk-based approaches can improve compliance (consistent application of a defined process focusing on product quality and patient safety) reduce the capital project timelines (improve ROI) and reduce life cycle costs (through reduction of the number of systems under GMP Change Control).

Implementation of these approaches tends to challenge traditional culture and practices. Users/Owners are making progress in transitioning from the current state (BG5) to the risk and science-based ASTM E 2500 (ICH Q9) approach. To date processes have not been fully defined and associated best practices have not been developed. Metrics to measure progress are necessary for owners/users to gauge alignment with industry trends and practices.

The C&Q CoP sponsors a User/Owner Task Team to compare approaches, identify current practices and benchmark progress against key principles in the transition process to a science and risk-based approach. At the previous two Annual Meetings this Task Team presented results of a survey conducted by this Team members and also surveyed the attendees present to compare results. The Team will continues to meet in 2011 to investigate the next steps – identifying the best practices and associated metrics to advance the transition process and explore the impact of the process on projects that involve legacy products as well as product life-cycle issues.

The third session of the series will include the following:

  • Task Team presentations
  • Overview presentations by the Speakers outlining the QRM/ASTM Verification programs being implemented by their respective organizations
  • Participant Survey to compare Task Team results to attendees experience on key elements of transition
  • Discussion Forum – Opportunity for attendees to challenge the panel

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 the challenges to be faced in implementing science and risk-based C&Q approaches
  • Benchmark your approach with other Pharmaceutical operating company professionals currently implementing risk-based methodologies
  • Determine the best approach for your organization based on insight gained

Who Should Attend

  • Project Engineers
  • Project Managers
  • Commissioning and Validation Professionals
  • Quality Professionals
  • Manufacturing Process Owners

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, C&Q, Engineering Standards Benchmarking, GAMP, HVAC, Oral Solid Dosage, and Project Management