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Chinmoy Roy
Biopharm Consultant,
Chinmoy 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. His latest presentation was as a panel member along with FDA personnel to discuss data integrity issues and also as a speaker on “Data Integrity Quality Issues” at the recently concluded worldwide conference of the International Society for Pharmaceutical Engineering (ISPE) in October 2014.
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Upcoming Training
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.
Live Session  Wednesday, January 21, 2015 11:30 AM PST | 02:30 PM EST,  Duration:90
Recorded Training
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.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

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.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

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.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

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.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

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.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.