Workshop Instructor
Chinmoy Roy
BSEE, MSCS
Subject Matter Expert: Data Integrity, GAMP, CSV, CFR 21 Part 11, Annex 11, Quality Risk Management, Manufacturing Process Automation and IT systems
Chinmoy Roy is an internationally recognized subject matter expert in CSV, CFR 21 Part 11, Annex 11, Data Integrity and manufacturing process automation systems. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF etc. Recently he was on the panel of experts on Data Integrity along with FDA inspectors to address Data Integrity issues. He is also a team lead in ISPE’s Data Integrity Special Interest Group (SIG), which recommends industry practices for Data.
His expertise stems from his 40 plus years of experience in implementing and obtaining “fit for use” certification for over 200 IT systems. He has worked at and consulted with leading US companies. His pioneering efforts in implementing CFR 21 Part 11 compliant systems in 1999 was a precursor to FDA’s issuance of Part 11’s Scope and Application guidance in 2003. His training workshops are unique in that he blends his field experience to provide case studies to explain the intricacies of implementing regulations. Chinmoy is an Electrical Engineer from Indian Institute of Technology, Kharagpur, West Bengal and a Masters in Computer Science from Worcester Polytechnic Institute from Worcester, MA, USA.
BSEE, MSCS
Subject Matter Expert: Data Integrity, GAMP, CSV, CFR 21 Part 11, Annex 11, Quality Risk Management, Manufacturing Process Automation and IT systems
Chinmoy Roy is an internationally recognized subject matter expert in CSV, CFR 21 Part 11, Annex 11, Data Integrity and manufacturing process automation systems. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF etc. Recently he was on the panel of experts on Data Integrity along with FDA inspectors to address Data Integrity issues. He is also a team lead in ISPE’s Data Integrity Special Interest Group (SIG), which recommends industry practices for Data.
His expertise stems from his 40 plus years of experience in implementing and obtaining “fit for use” certification for over 200 IT systems. He has worked at and consulted with leading US companies. His pioneering efforts in implementing CFR 21 Part 11 compliant systems in 1999 was a precursor to FDA’s issuance of Part 11’s Scope and Application guidance in 2003. His training workshops are unique in that he blends his field experience to provide case studies to explain the intricacies of implementing regulations. Chinmoy is an Electrical Engineer from Indian Institute of Technology, Kharagpur, West Bengal and a Masters in Computer Science from Worcester Polytechnic Institute from Worcester, MA, USA.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@FDAMap.com
