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.

Opening Keynote

In this session we will learn about the ValGenesis Smart GxP vision and how we help companies digitalize the process validation lifecycle through a closed-loop approach that leverages AI to help companies accelerate time to production, achieve "right-first-time" and improve quality and compliance.

Enabling Compliance and Efficiency: The Rottendorf Journey

Join Markus Jansen, manager DQ qualification to learn how Rottendorf Pharma rapidly implemented ValGenesis' validation lifecycle management solution and promoted adoption across the organization and the resulting improvements in the performance, accuracy and efficiency of their validation processes.

Enterprise-wide digitalization of CQV

Learn how a global pharmaceutical company is leveraging ValGenesis' validation lifecycle management solution to enable the enterprise-wide digitalization of their CQV processes across multiple sites.

The Value of a Closed Loop Process Life Cycle

In this session, Sandra 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.

Global Harmonization of QRM at CordenPharma

Learn about Corden Pharma’s objectives and experience with ValGenesis iRisk as they embarked on their journey to build an integrated Quality Risk Management Culture throughout Development and Lifecycle Management as part of their global QbD approach and endeavour increasing risk maturity and a risk based continuous improvement mindset as part of data accessibility and evaluation within the new PLS platform.

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 Modernized 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 modernize and future-proof their entire cleaning validation lifecycle. They are significantly reducing the risk of human error, 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.