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Adapting GxP Operations for Modern Compliance with Regeneron

Nov 05 | On-Demand

HighByte Webcasts Adapting GxP Operations for Modern Compliance with Regeneron

About this event

In GxP-regulated environments, compliance is more than a box to check—it’s a shared responsibility across IT, OT, and Quality. As manufacturers modernize operations and innovate, they must still meet the complexities of 21 CFR Part 11. It’s a paradox—and it’s solvable.

In this webinar, industry experts Ron Sherrod from Regeneron, Joseph Iuliucci from Interloopal, and John Harrington from HighByte discuss balancing innovation with compliance in pharmaceutical manufacturing. Watch to learn practical approaches, collaboration patterns, and enabling technologies that make modernization auditable, governable, and scalable.

Key topics covered include: 
  • CSA vs. CSV: Rethinking traditional validation to enable faster, smarter deployment of new technologies
  • Connected data for compliance: IT, OT, and Quality collaboration to simplify validation and improve governance
  • The partner ecosystem: Collaborating with trusted partners like HighByte and Inductive Automation to architect scalable, compliant solutions
  • Use cases: Real-world examples of innovating while meeting GxP compliance requirements