Chinmoy Roy is an internationally recognized process Automation/IT and compliance engineer. He is considered an implementation expert in the areas of S88/S95 ISA standards, cGMP, CSV, CFR 21 Part 11, Annex 11 and Quality Risk Management. With over 35 years of professional experience, he has facilitated numerous Quality Risk Assessments at US biopharmaceutical companies and has led several implementations of CSV and CFR 21 Part 11. He was a team member that pioneered the implementation of 21 CFR Part 11 in one of the largest paperless biotechnology manufacturing facility in the world. He is also a professional trainer. Chinmoy Roy held several positions at Foxboro, Texas Instruments, Siemens, CH2M Hill and Genentech. He holds a Bachelors degree in Electrical Engineering from the Indian Institute of Technology and a Masters in Computer Science from WPI, Mass. He lives with his wife and two sons in the San Francisco Bay area and his interests outside his profession include travel, current affairs and foreign cultures.