Validation has long been the bottleneck of digital transformation in regulated manufacturing, slowing every improvement, demanding the same effort regardless of risk, and built for a world where software changed infrequently. That model is breaking down, and a new one is taking its place.
In this session, you'll see:
- Risk-Based Foundations: How focusing validation effort on GMP risk, not testing every feature, replaces the old system-centric CSV model
- Engaging Relevant SMEs: Why business quality, not just IT/CSV, should drive risk assessments, and why that split matters
- Risk-Based Validation in Practice: How AstraZeneca, Jazz Pharmaceuticals, and Eli Lilly implement frameworks and tools to focus on GMP risk while scaling solutions across sites
- Rethinking Environments: Why legacy dev/test/prod habits add process without adding control
- AI as an Accelerator: How AI is already safely speeding up development and validation documentation
Who This Is For
Quality leaders navigating the shift from CSV to CSA, digital transformation teams adopting composable platforms, and IT/OT architects planning for AI in GMP environments.
Featuring:
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Michelle Vuolo
Head of Quality, Tulip
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Sydney Laing
Customer Success Manager, Tulip