Education Sessions
Quality Laboratory Facilities Baseline® Guide: Your Roadmap to a Compliant, Costeffective Lab (106)
| 29 October 12.45-15.45 | Track: Regulatory |
ISPE CEUs: 0.2
(PDF Current as of 2 October 2008)
This session provides an update on the development of the new Baseline® Guide for Quality Laboratory Facilities including application of principles of risk assessment, efficient and cost-effective commissioning and qualification, and existing international regulations surrounding the quality laboratory. At the time of this printing, the document development team is responding to global industry review comments and updating a draft to forward to the U.S. FDA.
There it will receive a formal technical and legal review. The anticipated publication date is first quarter 2009. The session will feature:
- Laboratory Guide overview, philosophy used in creating the Guide, and quality and compliance benefits of use
- Regulatory philosophy as it relates to facility design of quality control labs
- Application of ICH Q9: Quality Risk Management including particular risks to your laboratory situation based on current practices/strategies of your company
- Compliance through the application of ASTM E2500 vs. traditional C&Q
- Panel discussion/question and answer with Guide Authors
How You Will Benefit
At the end of this session, participants will be able to:
- Understand the major issues/updates to the Guide
- Describe regulatory challenges in laboratories
- Understand application of risk assessment in determining the quality strategies for your lab
- Analyze what risk assessment strategies you should consider for your laboratory
Who Should Attend
Laboratory, compliance and validation professionals, project engineers, architects, construction managers, and quality personnel
Session Leaders
- James O'Brien, President, NAMA Industries Inc., USA
- Rebecca Waterbury, Regulatory Compliance International, Abbott Vascular, Belgium
Session Speakers
- Frederick Fricke, Director, Forensic Chemistry Center, FDA, USA
- Catherine Middelberg, Manager, Engineering, Wyeth Biotech, USA
- Kimberly Snyder, Senior Technical Manager, Genentech, USA