Quality Laboratory Facilities Baseline® Guide: Your Roadmap to a Compliant, Costeffective Lab

Duration: 2.5 hours
ISPE CEUs: 0.2

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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.

The anticipated publication date is first quarter 2009. The session features:

• 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

Seassion Leaders

• James O'Brien, President, NAMA Industries Inc., USA
• Rebecca Waterbury, Regulatory Compliance, Abbott Vascular, USA

Session Speakers

• Frederick Fricke, PhD, Director, Forensic Chemistry Center, FDA, USA
• Catherine Middelberg, Manager, Engineering, Wyeth Biotech, USA
• Kimberly Snyder, Senior Project Manager, NNE Pharmaplan US, USA

Continuing Education Units or CEUs are a way to document time spent in educational programs. ISPE CEUs are calculated as follows: 1 CEU = 10 hours of education time. Thus 0.1 CEU is equal to one hour of education. Download a form to apply for the CEUs for this program.