Data Integrity continues to attract increasing attention of worldwide regulatory agencies. Although the need for data integrity has been in existence for a long time, it is only recently that it has received the focused attention of regulators.
While regulatory agencies are hiring computer savvy personnel to boost their data integrity audit staff, business expediency requires pharmaceutical management to also seek Data integrity training from qualified and experienced trainers with a track record of successfully designing, implementing and obtaining â€œfit for use certification for systems that fulfil data integrity requirements
CHINMOY ROY is one such person with a successful record of accomplishment for implementing data integrity on large systems in the pharmaceutical industry in the US. He has also established data integrity business processes at several companies in the US. During his training, he uses specific case studies from his personal experiences. These case studies demonstrate the fine nuances of Data Integrity. His US trainings that we have sponsored for the past 2 years have been full to capacity. We have received excellent feedback from his trainings in the US that we sponsored for the past two years. After success in the US We are glad to bring this training from the US.
US FDA Expert
Data integrity & CSV
Subject Matter Expert: Data Integrity, GAMP, CSV, CFR 21 Part 11, Annex 11, Quality Risk Management, Manufacturing Process Automation and IT systems
Chinmoy Roy has 35+ years of experience. He 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, Shimadzu’s annual conference for Asia Pacific, etc.
His expertise stems from his experience in implementing and obtaining “fit for use” certification for over 200 IT systems. He has worked at and consulted with leading US based companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. His pioneering efforts in implementing CFR 21 Part 11 compliant manufacturing IT systems in 1999 while employed by Genentech, was a precursor to FDA’s issuance of Part 11’s Scope and Application guidance in 2003. His 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 and a Computer Science post graduate.
World Compliance Seminars (WCS) is known all over the world for high quality of professional training programs it offers to members of the global biopharmaceutical community. While WCS has been mainly focussed in the US and European markets in the past, it is now bringing its highly popular and well-attended training on Data Integrity to India.
The 2 Day Conference and workshop will be mix of presentations, hands-on practical sessions, interactive workshops, case studies and Q/A sessions. Participants are encouraged to put forward their questions at the conference; these will be answered and discussed during the workshop.
Register T0 Data Integrity Audit Seminar 2017 Now!
Senior Analytical Chemist
Dalton Pharma Service
I learned a lot from the instructor and trainee good.
Senior Validation Engineer
Well placed, a lot of good information. Good interaction between participants. Held at a good location.
Well delivered seminars, right place, good contents.
Regulatory Compliance Manager
Charles River laboratories International, Inc.
I though the contents of the presentation and the discussion was very good.
Mr. David Stokes
IS Consulting & Compliance
I attended Chinmoy's overview of computer system validation at the June 2011 ISPE India Affiliate conference and found it to be a comprehensive overview of the current state of regulatory and industry guidance. It provided a broad perspective, introducing the many necessary elements and was well received by the audience.
Dr. D. Haldankar
Head Corp. Quality
Chinmoy visited our company for an in house training of our employees from several of our plants. I took the opportunity to be present for the training. I was impressed by the depth of his knowledge, both practical and regulatory, and the manner he approached our compliance questions that some the trainees brought to the class.
Mr. Biswajeet Mitra
I attended Chinmoy's CSV/Part 11/QRM training provided at our facility. His adroit answers to our application specific questions were very impressive and demonstrated the depth of his field experience and knowledge of regulatory requirements. On the recommendation of my employees, we have retained him as one of our consultants.