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.

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.

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 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.

From Digital CSV to Smart GxP – The ValGenesis Journey

Dr. Siva Samy, ValGenesis' founder and CEO describes the journey from the beginnings of ValGenesis to the ValGenesis Smart GxP vision. Learn 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.

Digitalizing the Process Validation Lifecycle: Empowering Practitioners and Transforming Pharma

Iris Ziegler, Ph.D., Director of Pharmaceutical Sciences and QbD, CordenPharma International
Verena Patek, Global Process Owner Corporate Quality, Bayer
Markus Krellman, Head of QA Data Quality Compliance, Rottendorf Pharma
Ângela Martinho, Vice President Delivery - Europe
Kenneth Pierce, Ph.D., Director of Product Growth, Cleaning and Process Validation

This panel brings together our speakers from today, who have successfully digitalized key aspects of validation: one in integrating QbD frameworks for CMC development, another in cleaning validation, a third in computer software validation and our own representative from product management. They will share not only the technical outcomes but also how practitioners are adapting, upskilling, and contributing to the overall digitization of validation. By exploring lessons learned, regulatory perspectives, and workforce impacts, the session will reveal how digitalization is elevating practitioners from process executors to strategic partners in pharmaceutical manufacturing.

Event Wrap-up