Schedule
Session Topics
Attendees will hear from leading validation, quality, and industry experts to deepen their understanding of best practices and emerging technologies for accelerating digital maturity. The 2026 agenda is below; the 2027 conference details will be shared later this year.
Tuesday
April 28
Wednesday
April 29
Thursday
April 30
5:00 pm
Reception
Customer and Partner Networking Reception
8:30 am
REGISTRATION
Customer Morning Registration
8:45 am
9:00 am
Customer Session 1
Customer Only: Product Vision and Roadmap
Donal O’Sullivan outlines Kneat’s strategic vision for AI in validation — from intelligent authoring and automated test execution to predictive compliance insights — and shares what’s on the product roadmap for 2026 and beyond.
10:10 am
Break
10:25 am
Customer Session 2
Customer Only: Cleaning Validation
Explore how Kneat is evolving to support end-to-end Cleaning Validation, from managing sample locations and risk data to enabling more dynamic, data-driven workflows. This session will showcase the current data model, preview upcoming capabilities like Calculations and Drawings markups, and highlight the future integration with LIMS to further streamline operations.
11:10 am
11:45 am
Lunch
Lunch
Forbes Street by Gareth Mullins12:30 pm
Registration
General Conference Registration
12:45 pm
1:00 pm
Keynote
Conference Keynote
A thought-provoking keynote exploring the intersection of mental performance, resilience, and high-stakes decision-making — and what the world of elite sport can teach the life sciences industry about sustaining excellence under pressure.
1:50 pm
Session 1.1
How Digital Validation was a key enabler to MSD ONECQV (Combining C&Q - CSV)
A practical case study on how MSD unified their Commissioning & Qualification and Computer System Validation programs into a single digital workflow using Kneat — reducing duplication, improving traceability, and accelerating site readiness.
Session 1.2
Kneat Product Session - eLogbooks
A deep-dive into Kneat’s eLogbooks module — covering configuration options, GxP compliance considerations, and real-world examples of how teams are replacing paper-based logbooks with a fully digital, audit-ready alternative.
2:30 pm
Break
2:45 pm
Session 2.1
Transforming Pharma Manufacturing: Sanofi's Journey Towards Digital Excellence in the Pharma 4.0 Era
Sanofi’s VP of Engineering shares how the organisation is navigating the shift to Pharma 4.0 — connecting intelligent automation, digital validation, and data-driven quality systems to drive efficiency across global manufacturing sites.
2:46 pm
Session 2.2
Kneat Product Session: Entities & CSV
An overview of how Kneat’s Entities framework and CSV capabilities support structured, risk-based validation of computerized systems — with practical guidance on template design, lifecycle management, and audit trail integrity.
3:30 pm
Session 3
Kneat Innovative Customer Award Sessions
Three Kneat customers — from Alcon, Colgate-Palmolive, and Pfizer — share how they have pushed the boundaries of digital validation, each recognized for exceptional innovation, adoption, and impact in their organizations.
5:00 pm
Closing Remarks
Day 1 Conference Closing Remarks
The Marker Suite5:30 pm
Reception
Buses Depart to Croke Park
6:00 pm
Reception
Offsite Evening Reception
Croke Park8:30 am
Welcome
Day 2 Conference Welcome and Partner Awards Presentation
Carey Ziegler opens Day 2 of Validate 2026, celebrating outstanding partner contributions with the annual Partner Awards before welcoming attendees into a full day of sessions across both tracks.
8:45 am
Session 4.1
Practical use of Kneat to standardize and simplify validation across global MODA-ES deployments at Lonza
A practical walkthrough of how Lonza leveraged Kneat to bring consistency and simplicity to their global MODA-ES validation programme — covering template standardization, cross-site alignment, and lessons learned from multi-site roll out.
9:30 am
Session 5.1
Pfizer’s Kneat Global Deployment Journey
Gisele Fahmi and Vasilios Tsatsaias share how Pfizer approached the global rollout of Kneat across their manufacturing network — covering governance, change management, and the measurable impact on validation cycle times.
9:31 am
Session 5.2
Kneat Integrations
A technical session exploring how Kneat connects with enterprise systems including ERP, LIMS, and document management platforms — with real examples of integration architectures built by Kneat customers and partners.
10:15 am
Session 6.1
AI in Validation & Quality: What’s Real, What’s Next
A panel of industry leaders cuts through the hype to examine where AI is genuinely delivering value in regulated validation today — and what organisations need to do now to prepare for the next wave of intelligent automation.
10:16 am
Session 6.2
Main Challenges Slowing Your Digital Validation (and How Top Teams Are Solving Them)
An interactive panel drawing on insights from Kneat’s global customer base — identifying the most common blockers to digital validation adoption and sharing the practical strategies that high-performing teams are using to overcome them.
10:55 am
Networking Break
Foyer11:15 am
Session 7.1
Driving Cost Reduction for C&Q Capital Projects with Digital Validation
Patrick Mullin from Sanofi presents a data-driven analysis of how digital validation has reduced cost and schedule overruns on capital commissioning and qualification projects — with specific metrics on efficiency gains and audit performance.
11:16 am
Session 7.2
How Alcon Uses Kneat as Catalyst for for Harmonization
Nathan Raschke and Daniel Weingand explain how Alcon used Kneat not just as a validation tool but as a strategic lever for harmonizing analytical science and technology practices across their global manufacturing and R&D sites.
12:00 pm
Session 8.1
Digital Validation at Eli Lilly
Jeff Denault shares Eli Lilly’s digital validation journey — from initial pilot through enterprise-wide adoption — including the organizational model, technical architecture, and cultural shifts that underpinned their success.
Session 8.2
Expert Panel: Implementation and Adoption: Strategies and Tactics
A practitioner-led panel exploring what separates successful digital validation implementations from stalled ones — covering stakeholder engagement, training approaches, change resistance, and the metrics that matter most.
12:40 pm
Lunch
Lunch
Forbes Street by Gareth Mullins1:40 pm
Session 9.1
Audit Readiness in a Digital Environment
A panel discussion on how digital validation fundamentally changes audit preparation — examining how teams are using Kneat to maintain a constant state of inspection readiness, respond faster to queries, and demonstrate robust data integrity.
1:41 pm
Session 9.2
Data Integration Platform - implementation and validation challenges
Grzegorz Janczewski presents a detailed case study on implementing and validating a data integration platform — addressing the unique CSV challenges posed by middleware systems and sharing a practical framework for managing integration risk.
2:25 pm
Session 10.1
Smart Commissioning in a Pharma 4.0 Smart Factory: A Digital CQV/CSV Ecosystem
Darren Crowe from AstraZeneca outlines how digital CQV and CSV are being woven into the fabric of a Pharma 4.0 smart factory — enabling real-time commissioning data capture, automated test execution, and seamless handover to operations.
2:26 pm
Session 10.2
Digital Validation Mastery: Enabling Validation 4.0
No deviation and ProcellaRX present a framework for achieving Validation 4.0 maturity — combining risk-based thinking, digital execution, and continuous improvement to move beyond compliance and into genuine operational excellence.
3:10 pm
Session 11.1
The State of Validation 2026: Accelerating Digital Maturity in the Age of AI
A comprehensive cross-industry panel assessing where the validation profession stands in 2026 — benchmarking digital maturity, examining the impact of AI, and identifying the actions organisations must take to accelerate their transformation.
3:45 pm
Session 11.2
Resilience Is a Validation Activity: We Rebuild, We Validate, We Protect
Elba Madouar delivers a powerful closing address on organizational resilience — drawing on her experience leading digital transformation through disruption and making the case that validation is not just a compliance function, but a cornerstone of business continuity.
