Chinmoy Roy
Chinmoy Roy has 40+ years of experience in the US Life sciences industry. He is an internationally recognized Subject Matter Expert (SME) in Data Integrity, CSV, CFR 21 Part 11, Annex 11 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. He has worked at or been a consultant for leading US companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. He has been on Data Integrity discussion panels with FDA inspectors. He travels worldwide to conduct CSV and Data Integrity training.

He was one of the early implementers of the world's largest fully paperless manufacturing automation IT system that conforms to 21CFR Part 11 and Data Integrity. He led a team of over 40 engineers and Validators to design the system and obtain ‘fit for use’ certification in 1999. His pioneering efforts in implementing that system while employed by Genentech, was a precursor to FDA's issuance of Part 11's Scope and Application guidance in 2003.
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Recorded Webinar
Ensuring Data Integrity through mapping DI, Part 11 and Annex 11
CFR 21 Part 11 and Annex 11 regulations were introduced to regulate the increasing use of computers in the biopharmaceutical industry. These regulations addressed the need for data's trustworthiness or integrity. While regulatory agencies provided the biopharmaceutical industry time to adapt their policies, procedures and practices to these regulations, they have recently started to enforce them routinely. Knowledge of the specifics of these regulations are essential to ensuring data integrity issues that have been addressed to the satisfaction of the regulators. Besides addressing the specifics of these regulations, the webinar will also help you understand the correlation between the attributes of data integrity and these regulations. This understanding is essential for the uncovering of potential DI problems in a company.
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Data Integrity Fundamentals
The biopharmaceutical industry finds itself under increasing pressure to focus on Data Integrity (DI). Auditors require companies to ensure that appropriate DI controls are implemented and appropriately managed throughout the data lifecycle. While industry comes to grips with the complexities of data integrity in their global supply chain, a series of webinars on DI are planned to assist your understanding on how to identify data integrity problems in your company and the steps you need to take to remediate them. Each webinar is designed to address a specific DI issue such as how to establish a corporate DI program, where does DI fit in the data lifecycle, mapping DI to existing predicate rules and how to design for DI during SDLC etc.
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IEC 62304: Medical Device Software Development and Validation
Software is a critical element because it ensures product quality and patient safety. Hence it always draws the attention of regulatory agencies such as the USFDA, EMA, TGA etc. The benefits accruing from devices and processes automated through software have been recognized.
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21 CFR Part 11 Complying with: Step by Step
There is an increasing use of computers and electronic data in the pharmaceutical industry. Consequently, management of electronic records and data continues to be a concern of the regulators. CFR 21 Part 11 regulations were enacted in 1997 to address those concerns.
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Bulletproofing your cGXP Documentation from Audit Citations
Regulators consider documentation to be a critical entity. Consequently, they always audit documentation systems and it is rare to find audits where 483s for poor documentation have not been issued.
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Use GAMP to Surefire your CSV Audit
Regulatory agencies have stepped up audits to aggressively enforce computer systems validation (CSV) and CFR 21 Part 11/Annex 11 implementation. A third of recent warning letters have cited improper validation and/or incorrect or deficient implementation. After a walkthrough of regulations for CSV, the presentation will transition to a brief explanation of validation enablers as enumerated in ISPE’s GAMP V guide to include the V-model and ASTM’s E-2500 standards. Finally, the webinar addresses e-Validation and their impact on ensuring that Validation is no longer a costly and risky activity.
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