Mr.Chinmoy Roy

Chinmoy Roy is an internationally recognized Subject Matter Expert (SME) in the areas of GAMP, Data Integrity, CFR 21 Part 11, Annex 11 and Quality Risk Management.  An engineer, with over 35 years of experience in major US biopharmaceutical companies, he has successfully installed and validated over 200 IT systems in the biopharmaceutical industry.  His practical experience along with case studies enables him to answer trainee specific questions, thereby providing them the background to take their learnings back to their work and use them immediately.  His training stresses critical thinking from first principles of compliance regulations.  He has been invited to present and conduct workshops at several professional conferences worldwide.  He has been a member of discussion panel member along with FDA personnel to discuss data integrity issues and also as a speaker on “Data Integrity Quality Issues” as invited keynote speaker at worldwide conferences.