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Chinmoy Roy
Biopharm Consultant,
Chinmoy Roy is a seasoned Life Sciences professional. His expertise includes the design, delivery and validation of industry compliant computerized and control systems for pharmaceutical and biotech manufacturing. His focus is on finding lean integrated manufacturing solutions to include Process Analytical Technologies (PAT), Quality by Design (QbD) and Quality Risk Management (QRM).

Chinmoy offers over 30 years of US based subject matter expertise in the design, development, QA, validation and CFR 21 Part 11 implementation for automation and computerized systems. As principal Lead Engineer, Chinmoy directed several engineering teams to design, commission, validate and obtain USFDA certification for multimillion dollars worth of computerized control systems. These systems were designed to be compliant with CFR 21 Part 11 requirements and conformant to ISA’s S88 and S95 standards.

Software Design Life Cycle (SDLC) and Software Design to ISA S88 and S95 standards, Computer Systems Validation (CSV), SME, Quality Risk Management (ICH Q9), Quality Governance (ICH Q10), CFR 21 Part 11 / Annex 11, Page1, USFDA and EMEA Inspection preparation and defence, Automation systems project management and ISA SP18 Alarm Systems Management and Design

Skills & Expertise
Validation, Computer System Validation, Automation, DCS, 21 CFR Part 11, GAMP, Quality Assurance, CAPA, Engineering, Software Validation, Commissioning and SDLC

Worcester Polytechnic Institute - MSCS, Electrical Engineering and Computer Science, 1980 - 1982
Indian Institute of Technology, Kharagpur - BSEE, Electrical Engineering, 1969 - 1974
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Upcoming 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.
Live Session  Wednesday, December 3, 2014 10:00 AM PST | 01:00 PM EST,  Duration:60
Recorded Training
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.