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Chinmoy Roy

Chinmoy Roy has 37+ 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.

 Seminar Id: IJ2018S3
05:30 AM PT | 08:30 AM ET
 Duration 2 Days

Computer Systems Validation (CSV) and Data Integrity

This interactive 2-day conference and workshop is for novices, advanced users, senior management and others who use computer systems for laboratories, clinical trials, manufacturing, quality and validation. This unique conference explores the latest industry standards such as GAMP V for validating data integrity, data access security, data transfer, data migration and audit trails. Addressed will be the development of dynamic programs d........

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