Schedule

Session Topics

Attendees will hear from leading validation and quality professionals, as well as Kneat and industry experts to expand their understanding of the technologies and best practices to accelerate their digital maturity. The 2026 conference theme and agenda will be shared later this year. 

"I love the experience. I've watched it grow over the last couple years, and it's amazing...the company has done a great job with promoting the system, the VALIDATE conference, and what Kneat can do to help promote greater productivity.”
Cindy White, Iovance Biotherapeutics

5:00 pm

Reception

Customer and Partner Networking Reception

8:30 am

REGISTRATION

Customer Morning Registration

8:45 am

Welcome

Customer Conference Welcome

Colum McNamara

Senior Vice President of Global Operations
Kneat
The Marker Suite

9:00 am

Customer Session 1

Customer Only: Product Vision and Roadmap

Donal O’Sullivan

Chief Product Officer
Kneat
The Marker Suite

10:10 am

Break

10:25 am

Customer Session 2

Customer Only: Cleaning Validation

Jamie Odonnell headshot

Jamie O’Donnell

Senior Product Manager
Kneat
The Marker Suite

11:10 am

Customer Session 3

Customer Only: AI Vision and Roadmap

Ruairi McGarry

Product Manager
Kneat

Gillian McMahon

Senior Product Owner
Kneat
The Marker Suite

11:45 am

Lunch

Lunch

Forbes Street by Gareth Mullins

12:30 pm

Registration

General Conference Registration

12:45 pm

Welcome

Conference Welcome

Eddie Ryan

CEO & Co-Founder
Kneat
The Marker Suite

1:00 pm

Keynote

Conference Keynote

Benjamin Bargetzi

Keynote Speaker
CEO Project MindGuard
The Marker Suite

1:50 pm

Accelerating Digital Maturity
Session 1.1

How Digital Validation was a key enabler to MSD ONECQV (Combining C&Q - CSV)

Dave O’Connor

C&Q Digital Transformation Manager
No deviation

Yvonne Owens

Associate Director, EMEA CQV Lead
MSD
The Marker Suite
Digital Validation Best Practices
Session 1.2

Kneat Product Session - eLogbooks

Lorna Whelan

Senior Product Manager
Kneat
The Shannon

2:30 pm

Break

2:45 pm

Digital Validation Best Practices
Session 2.1

Transforming Pharma Manufacturing: Sanofi's Journey Towards Digital Excellence in the Pharma 4.0 Era

Aine Fleming

VP, Head of Engineering Speciality Care
Sanofi
The Marker Suite
Digital Validation Best Practices
Session 2.2

Customer Only: Entities & CSV

Lorna Whelan

Senior Product Manager
Kneat

Daniel Tobin

Product Owner
Kneat
The Shannon

3:30 pm

Session 3

Kneat Innovative Customer Award Sessions

Andy Clarke

Director, Customer Success
Kneat

Cesar Tavarez

Sr. Engineer II - Validation
Alcon

Warren Ware

Validation Engineer
Colgate-Palmolive

Carly Cox

Senior Process Informatics Manager
Pfizer
The Marker Suite

5:00 pm

Closing Remarks

Day 1 Conference Closing Remarks

The Marker Suite
Reception

Drinks Reception

6:00 pm

Reception

Offsite Evening Reception

Croke Park

8:30 am

Welcome

Day 2 Conference Welcome and Partner Awards Presentation

Carey Ziegler

Manager of Partner Succes
Kneat
The Marker Suite

8:45 am

Accelerating Digital Maturity
Session 4.1

Practical use of Kneat to standardize and simplify validation across global MODA-ES deployments at Lonza

Fokke Zijlstra

Managing Director
Holoceen Projects B.V.
The Marker Suite
Digital Validation Best Practices
Session 4.2

Kneat AI Vision and Road Map

Donal O’Sullivan

Chief Product Officer
Kneat
The Shannon

9:30 am

Accelerating Digital Maturity
Session 5.1

Pfizer Digital Validation

Gisele Fahmi

Director, Content & Risk Mgmt Solutions Lead
Pfizer

Vasilios Tsatsaias

Manager and global Solution Owner
Pfizer
The Marker Suite
Digital Validation Best Practices
Session 5.2

Kneat Integrations

Joe Azzarella

Senior Customer Success Engineer
Kneat

Denis Bartley

Senior Integration Engineer
Kneat

Fintan Coady

CQV Specialist ORP Lead
PM Group
The Shannon

10:15 am

Accelerating Digital Maturity
Session 6.1

AI in Validation & Quality: What’s Real, What’s Next

Donal O’Sullivan

Chief Product Officer
Kneat

Emily Petrelis

Head of Facilities, Engineering & Global Pharma Validation
Nestlé Health Science, Pharma

Dori Gonzalez-Acevedo

CEO & Founder
ProcellaRX, LLC

Roisin Hickey

Founder -Principal Consultant
Qualirus

Phil Jarvis

Manager, CQV and digital validation
No deviation
The Marker Suite
Digital Validation Best Practices
Session 6.2

Main Challenges Slowing Your Digital Validation (and How Top Teams Are Solving Them)

Gisele Fahmi

Director, Content & Risk Mgmt Solutions Lead
Pfizer

Darragh Boyle

Manager, Consulting
Kneat

Clare Hehir

Customer Success Manager
Kneat

Andy Clarke

Director, Customer Success
Kneat

Paul Fahy

Director, Customer Enablement
Kneat
The Shannon

10:55 am

Networking Break

Foyer

11:15 am

Accelerating Digital Maturity
Session 7.1

Driving Cost Reduction for C&Q Capital Projects with Digital Validation

Patrick Mullin

Commissioning and Qualification Lead
Sanofi
The Marker Suite
Digital Validation Best Practices
Session 7.2

How Alcon Uses Kneat as Catalyst for for Harmonization

Nathan Raschke

Nathan Raschke

Head of Analytical Science & Technology
Alcon

Daniel Weingand

Head of Analytical Science and Technology
Alcon
The Shannon

12:00 pm

Accelerating Digital Maturity
Session 8.1

Digital Validation at Eli Lilly

Jeff Denault

Senior Advisor
Eli Lilly
The Marker Suite
Digital Validation Best Practices
Session 8.2

Expert Panel: Implementation and Adoption: Strategies and Tactics

Intoduction by CAI

Tim Akin

Customer Success Manager
Kneat

Aoife Hamilton

CQV Lead
GE Healthcare

Warren Ware

Validation Engineer
Colgate-Palmolive

Lindsay Settecasi ·

Director of Digital Validation
Verista
The Shannon

12:40 pm

Lunch

Lunch

Forbes Street by Gareth Mullins

1:40 pm

Accelerating Digital Maturity
Session 9.1

Audit Readiness in a Digital Environment

Patrick Mullin

Commissioning and Qualification Lead
Sanofi

Sarah Grogan

Customer Success Manager
Kneat

Denis Kelleher

Validation Engineer
Gilead Sciences

Yvonne Burazer

Associate Director, Senior Global Power User & Business Owner for paperless validation system
Takeda
The Marker Suite
Digital Validation Best Practices
Session 9.2

Data Integration Platform - implementation and validation challenges

Grzegorz Janczewski

CSV Manager
Rezon Bio
The Shannon

2:25 pm

Accelerating Digital Maturity
Session 10.1

Smart Commissioning in a Pharma 4.0 Smart Factory: A Digital CQV/CSV Ecosystem

Darren Crowe

Technical Lead – CQV & CSV
AstraZeneca
The Marker Suite
Accelerating Digital Maturity
Session 10.2

Digital Validation Mastery: Enabling Validation 4.0

Phil Jarvis

Manager, CQV and digital validation
No deviation

Dave O’Connor

C&Q Digital Transformation Manager
No deviation

Dori Gonzalez-Acevedo

CEO & Founder
ProcellaRX, LLC
The Shannon

3:10 pm

Session 11.1

The State of Validation 2026: Accelerating Digital Maturity in the Age of AI

Donncadh Nagle

Assistant Lecturer, School of Chemical & BioPharmaceutical Sciences
Technological University Dublin

Michael Sweeney

CQV Electronic Validation Lead
PM Group

Durward Sutherland

Validation and Compliance Manager IPS EMEA
IPS

Ruairi McGarry

Product Manager
Kneat
The Marker Suite

3:45 pm

Session 11.2

Resilience Is a Validation Activity: We Rebuild, We Validate, We Protect

Elba Madouar

Digital Transformation Leader
The Marker Suite

4:05 pm

Closing Remarks

Day 2 Conference Closing Remarks

The Marker Suite