Doors open

Welcome Session

David Medina kicks off the event with a warm welcome and a quick agenda walk-through. Get ready for a day of insights, customer stories, and forward-thinking innovation shaping the future of validation.

The ValGenesis Customer Experience - Journey to Value

This session will discuss how ValGenesis can help customers compress time-to-value from signature to go-live—using an outcome-based, consultative approach that drives a consistent, yet agile delivery model that allows for adaptability and speed.  Learn how our guided engagement approach allows you to define and implement your digital validation approach in alignment with your digital transformation strategy.

Digitalizing Validation - The Transcat Journey
Jonathan Revere - Director Global Validation Services
Jennifer Smyers - Validation Manager
Taylor Grimes - Assistant Validation Manager

Learn how Transcat utilized ValGenesis validation lifecycle management solutions to reduce average project turnaround times, increasing client satisfaction and saving 1,500 hours of documentation effort.

The Value of a Closed Loop Process Life Cycle

In this session, Ricardo will demonstrate how integrating Chemistry, Manufacturing & Controls (CMC) development with Continued Process Verification (CPV) in a closed‑loop validation lifecycle can turn disparate data streams into a self‑improving control system for pharmaceutical production. By continuously feeding real‑time performance insights back into process design and control strategies, manufacturers can accelerate regulatory readiness, improve product robustness, and reduce lifecycle costs while meeting ICH Q8–Q12 expectations.

From Development to Commercialization: Hansa’s Imlifidase Journey with ValGenesis
(Remote)

Learn how Hansa is leveraging ValGenesis to aggregate and manage the data supporting BLA readiness for Imlifidase, an innovative product for treating certain autoimmune conditions. ValGenesis Process Lifecycle Suite supports comprehensive review, curation and data structuring for all process development, process characterization, validation, and commercial batch data for the drug manufacturing process.

Panel Discussion: Reimagining the Process Validation Lifecycle through Digital Transformation, AI, and CSA
Daniel Matlis, President, Axendia
David Ladd, Director CSV Quality Assurance, Cardinal Health
Matthew Pincus, Scientific Leader, QbD & Digital Platforms, GSK (Remote)
Alton Johnson, PhD (Pharmaceutical Consultant)

Join a panel of seasoned industry leaders as they explore how digital transformation, artificial intelligence (AI), and Computer Software Assurance (CSA) are reshaping the process validation lifecycle. Drawing from real-world experience across Life Sciences, panelists will discuss the evolving role of digital tools in enhancing validation efficiency, ensuring data integrity, and aligning with modern regulatory expectations.

iClean: Digitalized Cleaning Validation Programs and Beyond

Dive with Kenneth into iClean’s latest features and streamlined UX/UI. Get a first look at the new Analytical Procedures module driving digital integration, higher OEE, continuous inspection readiness, and stronger product quality.

How Bayer Digitalized Cleaning Validation with ValGenesis

Learn how Bayer partnered with ValGenesis to deploy the industry’s first and only end-to-end, fully digitalized, risk-based cleaning validation solution to standardize and future-proof their entire cleaning validation lifecycle. They are increasing compliance and providing instant access to audit data enabling consistent compliance with internal policies and global regulatory standards.

Smart Validation Today: The Platform Vision in Action: Unifying Innovation, Driving Value, and Powering Your Next Upgrade
Kevin Shaw, VP Product Management, ValGenesis
Steve Reynolds, CRO, ValGenesis
Terrance Blackwell, CDO, ValGenesis
David Medina, CMO, ValGenesis
Michael Hulbert, Engagement Manager, Sikich LLC

Join the ValGenesis senior leadership team as they discuss the ValGenesis Smart GxP™ vision and how ValGenesis empowers companies to digitally transform their entire process validation lifecycle - from CMC development and design all the way through CQV and CPV.

Event Wrap-up