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.

Customer Session

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

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.

Customer Session

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.

Enabling Smart Validation Through AI

Join Gary in learning how biopharmaceutical manufacturers can improve and optimize their digital validation process with AI-powered Smart agents. Understand the challenges and concerns, such as validation, security, etc.) and how AI will help them to improve efficiency and quality, reduce costs and enable compliance.

Event Wrap-up