Robert W. Stotz, Ph.D., has more than 28 years experience in the pharmaceutical and healthcare industry, and is President of Validation Compliance Inc. (VCI) located in Exton, Pennsylvania. Dr. Stotz accumulated more than 11 years experience at The Upjohn Company (now Pfizer) in Kalamazoo, Michigan USA, culminating as Validation Manager for Upjohn's worldwide validation efforts, and nearly seventeen years in the validation services industry. Dr. Stotz works with many multi-national pharmaceutical and healthcare manufacturers in all aspects of operations (particularly computer systems) and validation, from concept through to system/facility qualification and start-up. He has been actively involved with validation issues for more than twenty-seven years and was a member of the Pharmaceutical Research and Manufacturers of America's (PhRMA's, formerly PMA's) Computer Systems Validation Committee for several years. He was also a member of the PDA's Computer Validation Committee that published PDA Technical Report No. 18 on “Validation of Computer-Related Systems,” and has presented and published several papers on the subject of validation. Dr. Stotz holds a doctoral degree from the University of Florida and B.S. and M.S. degrees from the University of Toledo. He can be reached at (610) 594-2182.