Education Sessions
Science and Risk-based Approach (for C&Q): Application of the New Guide, Volume 12 Science and Risk-Based Approach for the Specification, Design, and Verification of Facilities, Utilities and Equipment Systems Transition Case Studies (704)
| 28 October 14.15-17.15 | Track: Efficient and Effective Compliance |
ISPE CEUs: 0.2
(PDF Current as of 9 October 2008)
Review a series of case studies showing initial industry approaches to transition from the original C&Q Baseline Guide approach using impact assessment to science and risk-based approaches described in ASTM E2500 and the New C&Q Baseline Guide. Following the presentation, a speakers’ panel will hold a discussion session with the audience to clarify points of interest. This session compliments session 703. You may wish to register for both if you are interested in this topic.
How You Will Benefit
At the end of this session, participants will be able to:
- Understand the transition from Impact Assessment to Risk-based approaches
- Have a better understanding of the verification process
- Understand the difference between the new and original C&Q Baseline Guides
Technical Documents - www.ISPE.org/publications
Commissioning and Qualification Baseline® Guide
Who Should Attend
All multi-disciplined project teams which are responsible for demonstrating that manufacturing elements are Fit For Use (i.e. qualified) to produce pharmaceutical products meeting quality requirements. This includes engineering, quality, SMEs, R&D, operations, among others.
ISPE Communities of Practice (COPs)
All COPs
Session Leader
- Steven Wisniewski, Sr Assoc Director of Compliance, IPS, USA
Session Speakers
- John Robert Adamson, Mgr Compliance & Validation, Foster Wheeler Energy Ltd, United Kingdom
- Elizabeth Bramhall, Director Validation, Bayer Tech. Services, USA
- Kimberly Dahmen, Manager, Eng'g Assurance, Abbott Laboratories, USA
- Rose Mary Dollard, Manager, Commissioning and Qualification Services, Johnson & Johnson, USA
- Michael O'Neal, Director, Worldwide Engineering & Real Estate, Johnson & Johnson, USA
- Jorge Rodriguez, President, , USA
- Michelle Whipple, Assoc Dir, QA Validation, Bristol-Myers Squibb, USA