Mr. Chinmoy Roy is a biopharmaceutical consultant. He is a SME with over 38 years of experience in CSV, Data Integrity, 21 CFR Part 11, Annex 11 and manufacturing process automation. He is a member of ISPE’s Data Integrity Special Interest Group (S.I.G). He directed a team of over 60 people in the design, commissioning and Validation of a Manufacturing IT system at world’s largest biopharmaceutical facility located in CA, USA. He travels the world to train industry personnel in the areas of his subject matter expertise. His interactive trainings blend his field experience and highlights the practical challenges in implementing regulations. Chinmoy has also assisted former FDA auditors in auditing their clients for Data Integrity and CSV issues. Chinmoy has a bachelor’s degree in Electrical Engineering and a Master’s degree in Computer Science. He lives in the San Francisco bay area.