Conference Day Two:  Wednesday, October 15, 2008

(Continued from Conference Day One)

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:

7:45 AM - Optional Roundtable Breakfast
                  So, My Computer System Needs To Be Validated - What Do I Do Now?
                  Lois Preis White, Consultant, Wyeth Consumer Healthcare

8:00 AM - Contintental Breakfast   

8:30 AM - Workshop Resumes

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

12:00 PM - Workshop Concludes with Lunch

 GENERAL SESSION

1:30 PM - 3:00 PM  Benchmark Group Discussion and Knowledge Sharing Session

3:00 PM - 3:15 PM  Refreshment Break & Exhibit Viewing

3:15 PM - 5:30 PM  Benchmark Group Discussion and Knowledge Sharing Session (continues)
 
5:30 PM - Benchmarking Ends