Conference Day Three:  Thursday, October 16, 2008

7:45 AM - Optional Rountable Breakfast
                  Computer Validation - Are We Doing Too Much?
               Richard Van Culin, Manager, Regulatory Compliance, Boehringer-Ingelheim

8:15 AM - Chairperson's Opening Remarks
                  Vimarie Ortiz, Operational Partner, Processo Partners, Inc.


GENERAL SESSIONS

8:30 AM - Computer Systems Industry Standard: What the FDA Looks For in an Inspection
                  David Nettleton, FDA Compliance Specialist, Computer System Validation

9:15 AM - A New Part 11?  The Critical Issue of Data Integrity
                  Martin Browning, President, EduQuest, Inc.

10:00 AM - Refreshment Break & Exhibit Viewing

10:15 AM - What Can GAMP 5 Do For You?  The New and Improved GAMP - A Cost-Effective 
                     Approach to Achieving Compliance
                     Lois Preis White, Consultant, IS Compliance, Wyeth Consumer Healthcare

11:00 AM - The Rubber Meets the Road: A Different Risk-Assessment Approach Used to Focus 
                     Effort and Reduce Costs
                     Greg A. Sears, Validation Manager, Lonza Biologics, Inc.

11:45 AM - Changing the Validation Mindset: Optimizing and Streamlining the Validation
                     Process via Lean System Validation
                     Vimarie Ortiz, Operating Partner, Processo Partners, Inc.

12:30 AM - 1:30 PM  Luncheon


1:30 PM - 3:00 PM   INTERACTIVE EXERCISES (A-D)

Interactive Exercise A
Risk-Based Approaches for Computer System Validation: Which One Do I Choose?
Richard Van Culin, Quality Assurance, Boehringer Ingelheim

Interactive Exercise B
A Risk-Based Approach to Writing Winning Test Scripts
Tom Stocks, BS ACS, Sr. QA Systems Administrator, Teva Pharmaceuticals USA
Vimarie Ortiz, Operating Partner, Processo Partners, Inc.

Interactive Exercise C
Defining Requirements: Reducing the Pain and Increasing Your Return
Tim Stein, Ph.D., Director of Software Validation and Quality Assurance, Genomic Health, Inc.

Interactive Exercise D
Handling Deviations and Deficiencies During Validation
Susan B. Cleary, B.CS, M.B.A., Director of Product Development, Novatek International


3:00 PM  Refreshment Break & Exhibit Viewing


3:30 PM - 5:00 PM  INTERACTIVE EXERCISES (E-H)

Interactive Exercise E
Best Practices for Executing and Documenting Testing - How to Save Time, Reduce Rework, and Still
Meet Regulatory Expectations
Aaron Harlett, Sr. Systems Analyst - Computer System Validation, Eli Lilly and Company

Interactive Exercise F
Auditing a Computer System Validation Program in a Risk-Based Environment
Heather Reilly, M.S., CQA, Quality Assurance Manager, Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.
Richard Van Culin, Quality Assurance, Boehringer Ingelheim

Interactive Exercise G
Leveraging Vendor Qualifications to Reduce Validation Costs
Tom Stocks, BS ACS, Senior QA Systmes Administrator, Teva Pharmaceuticals USA

Interactive Exercise H
"But I Thought W Were Done!"  Practical Change Control in a Regulated Environment
Tala Davidson, M.S., Subject Matter Expert, most recently at Pfizer Inc., roles include research and 
development, manufacturing, project management, and information technology