"GLP Bioanalysis offers a wealth of knowledge and experience from scientists and managers who have thoughtfully and with care, implemented GLP and SOP's to 'build a better future'."

Tuesday, October 25, 2005

8:00 Morning Coffee, Poster and Exhibit Viewing

9:00 How to Write Effective SOPs
Dr. Anne Maczulak, Acorn GLP Consulting
Standard Operating Procedures are one of the key elements of GLP facilities and studies, yet they are often incomplete or poorly organized by many companies and universities. This presentation will cover (a) the activities that must be captured in SOPs for regulatory compliance, (b) tips for writing effective SOPs, and (c) methods for managing them, from authorship to discarding of old versions.

9:30 Introduction to the Common Technical Document and Electronic Submission
Dr. Alex D. Kanarek, President, Bio-Development Consulting Services

10:00 Coffee Break, Poster and Exhibit Viewing

10:30 Image Compression and 21 CFR Part 11 Compliance
Dr. Mark W. Tengowski, Associate Director, Global Clinical Platforms, Pfizer Global Research and Development
Image analysis provides the answer to those looking for quantitative solutions in an otherwise descriptive discipline, such as toxicologic pathology. Developing an infrastructure to perform studies in a regulated environment has both short- and long-term difficulties in understanding how to apply 21CFR parts 58 and 11 to a digital process. This talk will demonstrate one way to qualify a capture platform, segment images both automatically and with color cube-based thresholding, and include a discussion of image compression. Understanding the biological and technical error in recreating data points akin to an audit should help guide you in creating your own protocols.

11:00 Mitigating Validation of a Bioanalytical LIMS System
Mr. Gregory Samoil, EP Product Manager, Informatics Division, Thermo Electron Corp.
The U.S. Food and Drug Administration (FDA) developed Part 11 of Title 21 of the Code of Federal Regulations (known as 21 CFR Part 11) with the intent to promote the widest possible use of electronic technology in a way that was compatible with their responsibility to promote and protect public health. Deployment of a Bioanalytical LIMS system and its validation involves people, actions, protocols, scripts, testing and a very large number of documents. An initial thorough validation plan can ensure successful validation and effectively reduce the amount of effort and resource to deploy subsequent versions of the system. The various elements of a detailed validation plan will be discussed, as will many of the various activities and other documents required.

11:30 Panel Discussion: 
Implementation Experiences Creating a GLP Image Analysis Workstream: 
Qualifying from Capture to Final Storage
Moderator: Dr. Mark W. Tengowski, Associate Director, Global Clinical Platforms, Pfizer Global Research and Development

12:15 End of Conference