Conference Day One:  Tuesday, October 14, 2008

Interactive Pre-Conference Workshop:

UNDERSTANDING, DEVELOPING, AND IMPLEMENTING
BEST PRACTICES FOR A COMPLIANT COMPUTER SYSTEM VALIDATION PROGRAM

Comprehensive 4-Part Workshop Agenda:

Part 1 - Computer System Validation Basics
Part 2 - Pretest Deliverables: Validation Plan, Requirements, Risk Assessment, Design Description
Part 3 - Testing: Writing Good Scripts, Executing Scripts, Handling Deviations
Part 4 - Post Testing: Summary Report, Change Control, Maintenance

Workshop Instructors:

Susan B. Cleary, B.CS. M.B.A., Director of Product Development, Novatek International
Tala Davidson, M.S., Subject Matter Expert, most recently at Pfizer, Inc.
Denise Dion, Senior Regulatory Consultant, EduQuest
Erik Muegge, Assistant Director, Technology Compliance, Alcon Inc.
Vimarie Ortiz, Operational Partner, Processo Partners, Inc.
R. Timothy Stein, Director, Software Validation and Quality Assurance, Genomic Health, Inc.

Workshop Schedule:

8:00 AM - Registration and Continental Breakfast

8:30 AM - Workshop Begins With Chairperson's Opening Remarks
                   Vimarie Ortiz, Operational Partner, Processo Partners, Inc.

10:00 AM - 10:15 AM  Refreshment Break & Exhibit Viewing

12:00 PM - Luncheon

1:00 PM - Workshop Resumes

3:00 PM - 3:30 PM  Refreshment Break & Exhibit Viewing

5:00 PM - Day One Concludes

5:00 PM - 6:00 PM  Networking Reception