Applied Pharmaceutical Software 2008

Meeting Theme:

Total Electronic Solutions in the Bioanalytical Lab

8:30 - 9:00 Introduction to Meeting: Industry Survey Results
9:00 - 10:15

Session 1: Electronic Lab Notebooks
Adam Brockman, Merck, moderator

Electronic Tablets, Pat Bennett, Tandem

Implementation of Electronic Record Keeping in a Clinical Bioanalytical Laboratory - Lessons Learned and Demo, Sheila Breidinger & Brad Roadcap, Merck

10:15 - 10:45 Break
10:45 - 12:15

Session 2: LIMS
Tom Huggins, P&G, moderator

Watson/Biobook Critiques, Todd Stawicki, Merck

Data Mining as a Strategy to Enhance the Quality of BA Method's Development (MD) / Validations, Murali Reddy, Schering-Plough

Increasing Sample Throughput and Accuracy in a GLP Bioanalytical Facility Using a Computer Application to Create Readable Files for Most Automation Platforms, Todd Branch, P&G

12:15 - 1:15

Luncheon Workshop: Sponsored by Thermo

The Current and Future of Watson LIMS, ECM and Content Management for Electronic Submissions, Kim Shah, Thermo Scientific Informations Division

1:15 - 3:00

Session 3: Data Capture, Transfer & Archiving
Surendra Bansal, Roche, moderator

Managing Raw Data in the Regulated Paperless Lab – A rational approach, Guy Talbot, Consultant

Experience in the Use of NuGenesis Archive System in a Bioanalytical Laboratory, Andrew Jayaraj, Vertex

User Experience with Agilent ECM, Dave Agrella, PPD Pharamco

Poster Intro: Standard data formats for analytical systems: Status and challenges, Maren Fiege, Waters

3:00 - 3:30 Break
3:30 - 5:00

Session 4: Automated Report Writing & Data Release
Chris Kemper, PharmaNet, moderator

Bioanalytical Reporting from a Custom LIMS Application Gerry Gormley, GSK

Automated Report Writing; First Principles and Practical Applications, Brian Lilley, Agilux

Bridging Bioanalytical Applications with Inspectors: An Electronically Developed QA Program, Susan M. Petersen, Advion

5:00 - 6:00

Session 5: Linking Everything Together
Mark Arnold, BMS, moderator

Integration of Automated Data Reporting Systems with Operational Workflows, Stacey Popma, Alta

Wrap-Up & Panel Discussion: Current Review of Data Systems, Mark Arnold, BMS

6:00 - 7:30 Wine and Cheese Networking Reception: Sponsored by Agilent