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HomeWebinarsModernizing Computer System Validation (CSV) for Connected Biopharma Manufacturing

Modernizing Computer System Validation (CSV) for Connected Biopharma Manufacturing

Webinar

As pharma and biopharma manufacturing becomes more digital and connected, validation complexity grows. Learn best practices for computer system validation (CSV) such as mapping the flow of critical data, including a user requirements specification, lifecycle management, and implementing a risk-based approach.


In this webinar, you will learn:

  • Why CSV is increasingly critical in connected, software-enabled GMP environments
  • Best practices for managing CSV complexity and data integrity across integrated manufacturing environments
  • How Computer Software Assurance (CSA) sifts validation from exhaustive testing to risk-based assurance

Speakers

Tri Hoang

Tri Hoang

MilliporeSigma

Integration and Implementation Lead

As a skilled System Architect, Tri Hoang is a full-stack developer with over 17 years of experience in the software development lifecycle, with a particular focus on working in GMP environments. Currently, he builds and integrates business intelligence applications to support complex pharmaceutical manufacturing production processes. Prior to joining our company, Tri held various roles as a software engineer, senior analyst, and business integrator at Baxter International, Elano, and Connected Healthcare. Tri holds a BS and MS in Computer Science from Georgia State University

Harish Narayan

Harish Narayan

MilliporeSigma

Strategic Product Manager - Digital Solutions

Harish leads the strategy, definition, and commercialization of a new digital services portfolio for our biopharma customers including predictive modeling for upstream and downstream processing, digital twins, computerized system validation (CSV), and advanced analytics and automation integration. He has led consultative sales of complex software solutions, shaped digital product offerings, and spearheaded technology efforts in life sciences, fintech, healthcare, ecommerce, and SaaS. Harish holds a master’s degree in computer science from the University of Texas at Arlington, and an MBA from Southern Methodist University in Dallas, Texas.