Validation Without Theater: Checks, Trust, and Automation

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Speakers

Host<br>Aga Rasińska

Host
Aga Rasińska

Associate Director of Strategy

Ashley Tarasiewicz

Ashley Tarasiewicz

Director, Head of OpenVal®

Maya Gans

Maya Gans

Associate Director, Analytics Engineering

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Tired of validation that feels like theater? Join Ashley, Maya, and Aga for an unscripted, expert-led conversation on what builds trust in regulated pharma environments without drowning in paperwork. 

This session goes beyond checklists and buzzwords to focus on decisions teams face every day:  

  • When to validate tools versus outputs and how to justify that choice 
  • How to avoid re-validating what’s already trusted 
  • How to design checks that scale without entering a manual review rabbit hole 

We’ll demystify verification versus validation in plain language, introduce practical review and ‘delta’ thinking, and share concrete examples from our years of work. We’ll also provide a grounded take on AI in validation, including where assistive AI adds value, where it’s risky, and where it simply doesn’t help. 

Expect honest opinions, real scenarios, and lessons learned from the field — not theoretical frameworks or regulatory fairy tales. You’ll leave with practical knowledge your team can use immediately, clearer language to align stakeholders, and the confidence to apply right-size validation effort to actual risk. 

  • Why validation often becomes performative instead of truly risk-based  
  • What the real effort of validation is 
  • What checks increase confidence and which only fill documentation  
  • AI in validation: where it helps, where it’s dangerous, and where it’s useless  
  • How to design scalable checks without creating review bottlenecks  
  • Trust-first validation. Replace validation theater with steps that prioritize decision confidence.  
  • Shared language. Plain-English definitions of verification, validation, and IQ/OQ/PQ grounded in daily work.  
  • Tool vs output. A practical rule of thumb for when validation can be light touch and when outputs require full QC.  
  • Layers & delta review. Stop re-validating what’s already validated; focus only on what changes trust.  
  • AI without hype. Where assistive AI adds value, where it’s risky, and where it’s just noise.