This week, Stacey is joined by Chinmoy Roy to answer some important questions about the current state of digital transformation across the pharmaceutical industry. Digital transformation in the pharmaceutical industry is crucial for better patient care, cost-effectiveness, greater transparency, improved production, and drug development. Across the pharmaceutical industry, companies are at varying stages in the adoption of digital technologies, but it is clear that the recent COVID pandemic may have accelerated this process for all by about 3 to 4 years. So where are we now as an industry, and what are companies doing to move toward a strategic digital transformation plan?


 


About Our Guest:


Chinmoy Roy is a seasoned Life Sciences professional with 40 years of hands-on and managerial experience in the life sciences industry. He brings extensive implementation experience in engineering, CCSV (Computerized and Cloud Systems Validation), Data Integrity, and IT compliance, providing the foundation for his consulting and training services. His training in CCSV and Data Integrity has been meticulously developed to disseminate the understanding of industry regulations from fundamental principles of science, engineering, and technology. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF, Shimadzu's annual conference for the 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 implementors 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 the FDA's issuance of Part 11's Scope and Application guidance in 2003.


 


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