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.
Join industry experts Ron Sherrod from Regeneron, Joseph Iuliucci from Interloopal, and John Harrington from HighByte for an in-depth discussion on balancing innovation with compliance in pharmaceutical manufacturing. 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
