C&Q Risk Task Team Forum IV

Tools and Templates

Session 103
Regulatory Track

Streamlined commissioning and qualification processes based on science and risk approaches can improve compliance, reduce the capital project timelines and reduce life cycle costs. Implementation of the risk-based approach to commissioning and qualification tends to challenge traditional culture and practices. Users and Owners are making progress in transitioning from the current state (BG5) to the science and risk (ICH Q9) approach. To Date processes have not been fully defined and associated best practices have not been developed.

Session Description

Identify the best practices and associate tools to drive an efficient and effective science and risk-based approach to C&Q. The C&Q Task Team will present tools and templates representing best practices from companies implementing the science and risk based approach concepts. There will also be a discussion forum to get your questions answered. Example applications will also be presented.

The session will include the following:

Task Team presentation on tools and templates representing best practices from companies implementing the science and risk based approach concepts.
Present example applications (e.g. User Requirements, Design Reviews, Traceability Matrices, etc.)
Discussion Forum – Opportunity for attendees to question the panel

At the conclusion of this session, participants will:

Gain an understanding of tools and templates as applied to the science and risk-based C&Q
Learn about best practices being implemented by other companies
Determine the best approach for your organization based on insight gained

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