Practical Application of C&Q Applied Risk Management

Sessions 401
Facilities and Equipment Track

Many pharmaceutical companies have traditional C&Q programs embedded within their quality systems used for the control and maintenance of manufacturing and facility systems. It is difficult to introduce new concepts within these quality systems due to the business impacts when changes are made. A phased approach to the risk-based C&Q key elements across each of the functions within a manufacturing facility (utilities to manufacturing) introduced systematically over time will allow for a smooth transition to a more effective and efficient C&Q program while maintaining business continuity.

Session Description

There have been several recent regulatory and industry guidance documents published that support the concept of a science and risk based (QRM) C&Q program will be used for discussion. These include the revised FDA Guidance for Industry: Process Validation: General Principles and Practices (January 2011), ASTM E2500 - 07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, ISPE “FSE” guide and ISPE GPG: Applied Risk Management for Commissioning & Qualification. This session will teach delegates how to create or enhance current C&Q programs with solid risk-based principles for every aspect of the pharmaceutical manufacturing environment, as well as develop and present specific risk-based C&Q tools and work instruction for low-impact implementation.

At the conclusion of this session, participants will be able to:

Develop and present specific risk-based C&Q tools and work instruction for low-impact implementation
Create or enhance current C&Q program with solid risk-based principles for every aspect of the pharmaceutical manufacturing environment

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