Schedule

Session Topics

Two tracks over two days, including multiple sessions, dinners, networking drinks, and social events. Customers join early, with customer-exclusive pre-event sessions on Day One.

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6:00 pm

Customers
Reception

Customer Only Reception

Bayview Ballroom

8:30 am

Customers
REGISTRATION

Registration & Breakfast

Foyer

9:00 am

Customers
Welcome

Customer Conference Welcome

Colum McNamara

Senior Vice President of Global Operations
Kneat
Grand Ballroom

9:15 am

Customers
Session 1

Product Roadmap Round Table

Ruairi McGarry

Product Manager
Kneat

Keith Holmes

Chief Technical Officer
Kneat
Grand Ballroom

10:15 am

Customers

Break

Foyer

10:30 am

Customers
Session 2

Kneat Gx Version 9.x Pre-Release Demonstration

Ruairi McGarry

Product Manager
Kneat

Trish Reardon

Solutions Engineer
Kneat
Grand Ballroom

11:15 am

Customers
Session 3

Process Engineering Governance Framework

Jamie Odonnell headshot

Jamie O’Donnell

Manager, Customer Success Engineering
Kneat
Grand Ballroom

12:00 pm

Customers

Lunch

Lower Pool Deck

12:30 pm

REGISTRATION

General Conference Registration

Registration for Kneat Customers begins at 8:30am before the Customer-only morning sessions

Foyer

1:00 pm

Welcome

Conference Welcome

Eddie Ryan

CEO & Co-Founder
Kneat
Grand Ballroom

1:15 pm

Keynote

Embracing Change: Unlocking Success in the Digital Age

In today’s fast-paced digital age, organizations are constantly bombarded with new technologies, operational challenges, and ever-evolving expectations. Join us as we explore strategies and techniques to ensure organizations recognize and adopt digital change. Discover how our R.E.A.D.Y. framework can help you design a plan to encourage organizational adoption of change and unlock success in the digital era.

April Callis-Birchmeier

Change Management Consultant
Springboard Consulting, LLC
Grand Ballroom

2:05 pm

Digitization and Organization Change
Session 1.1

Case Study: Harnessing Kneat Implementation as a Change Agent for Harmonization

Kate Brattlie

Senior Manager of Computer System Validation and Assurance
National Resilience, Inc

Amy Kuntzman

Principal Consultant
CAI

Tamara Redondo

Senior Manager, Digital Quality Systems
National Resilience, Inc
Grand Ballroom
Digital Validation Best Practice
Session 1.2

Panel Discussion: Kneat Services in Industry

Sarah Grogan

Customer Success Manager
Kneat

Priscilla Gibbons

Partnership Success Manager
Kneat

Paul Fahy

Manager, Partner Success & Kneat Academy
Kneat
Jamie Odonnell headshot

Jamie O’Donnell

Manager, Customer Success Engineering
Kneat
Salon A

2:50 pm

Break

Foyer

3:05 pm

Digitization and Organization Change
Session 2.1

Advantages of Digital Qualification for EPCM Projects

Dr. Clemens Borkenstein

Corporate Head of Executive Quality
Zeta
Grand Ballroom
Digital Validation Best Practice
Session 2.2

Case Study: How Veqtor & Kneat Rapidly Digitized Risk-Based CSV for Dechra Pharmaceuticals PLC

Kristan Baker Headshot

Kristan Baker

Director of US Kneat Services, Capital Projects & Digital Transformation
VEQTOR
Salon A

3:55 pm

Digitization and Organization Change
Session 3

Audit Readiness

Kathianne Ross

Manager of IT Compliance
Fujirebio Diagnostics, Inc.
Grand Ballroom

4:40 pm

Day 1 Conference Close

Art Gehring

VP, Marketing
Kneat
Grand Ballroom

5:00 pm

Drinks Reception

Upper Pool Deck

6:00 pm

Networking Dinner Sponsored by Design Group

Rob Beane headshot

Rob Beane

Partner & Practice Leader
Barry-Wehmiller Design Group
Lower Pool Deck

8:30 am

Breakfast

Continental Breakfast

Foyer

9:00 am

Digitization and Organization Change
Session 4

Digital Validation: Going Beyond Implementation With Merck

Ryan Dunn

Global C&Q Lead, Global Engineering Solutions
Merck

Dave O’Connor

C&Q Digital Transformation Manager
No deviation
Grand Ballroom

9:50 am

Digitization and Organization Change
Session 5.1

Inspection Readiness in the Digital Age

Aubrey Hogan

Service Line Leader - Regulatory, Compliance & Product Lifecycle Management
Verista
Grand Ballroom
Digital Validation Best Practice
Session 5.2

Panel Discussion: Future Opportunities with Digital Validation

Dave O’Connor

C&Q Digital Transformation Manager
No deviation

Aaron Jordan

Managing Partner
DT Partners

Carolina Costa

Senior Specialist Multi Site Validation
GSK Vaccines

Lori Kim

VP, Technical Operations
PSC Biotech
Salon A

10:35 am

Break

Foyer

10:50 am

Digitization and Organization Change
Session 6

Panel Discussion: Organization Structure & Change Management

Rob Beane headshot

Rob Beane

Partner & Practice Leader
Barry-Wehmiller Design Group

Matthew McMenamin

Validation Global Process Owner, Quality
GSK

Nathan Storie

Associate Director, Global Lead Power User, e-Validation
Takeda
Grand Ballroom

11:45 am

Digitization and Organization Change
Session 7.1

Mock Audit: Navigating Audits Using Digitized Validation

Audrey O’Reilly

Director, Global Quality & Compliance
Merck & Co

Patrick Mullin

Commissioning and Qualification Lead
Sanofi
Grand Ballroom
Digital Validation Best Practice
Session 7.2

Demonstration: Kneat Gx

Trish Reardon

Solutions Engineer
Kneat
Salon A

12:30 pm

Lunch

Lower Pool Deck

1:35 pm

Digitization and Organization Change
Session 8.1

Panel Discussion: Quickly Deploying Change Control

Kathianne Ross

Manager of IT Compliance
Fujirebio Diagnostics, Inc.
Dan Medeiros headshot

Dan Medeiros

Validation Engineer
Barry-Wehmiller Design Group

Tim Akin

Customer Success Manager
Kneat
Grand Ballroom
Digital Validation Best Practice
8.2

Pharma 4.0: How Emerging Technologies Like AI and AR Will Transform Life Sciences Operations

Nick Armstrong

Senior Director, Digital Enablement
CAI
Salon A

2:25 pm

Digitization and Organization Change
9.1

The Future of Validation – Digital Validation with AI

Viraj Karekar

C&Q Manager
MMR Consulting

Bruce Klopfenstein

Senior CQV PM
MMR Consulting
Grand Ballroom
Digital Validation Best Practice
9.2

Why Proper Digital Implementation is Critical to Scalable Success

Sean O’Leary

Managing Partner
PCI Pharma

Aaron Jordan

Managing Partner
DT Partners
Salon A

3:15 pm

Digitization and Organization Change
10

Case Study: How Eli Lilly & Co Digitized Validation

Thao Phan headshot

Thao Phan

Advisor, Engineering Technical Center
Eli Lilly and Company
Kristan Baker Headshot

Kristan Baker

Director of US Kneat Services, Capital Projects & Digital Transformation
VEQTOR

Elizabeth Weaver

Senior Principal Engineer – Automation CSV and Data Integrity
Eli Lilly and Company
Grand Ballroom

3:55 pm

Day 2 Conference Close

Derek Hughes

VP US Sales
Kneat
Grand Ballroom

4:00 pm

Light Refreshments

Foyer