Data, Decisions & Dinner: A Walk Through Pharma 4.0 Validation
Validation 4.0 – Driving the Future of Pharma 4.0™
6 November 2025 | 13:00 – 20:00
Poortgebouw, Leiden Bio Science Park – a 2-minute walk from Leiden Centraal
About the event
The ISPE NL Community of Practice Pharma 4.0™ is proud to host its first in-person event. The central theme is Validation 4.0.
Why this event matters
Validation 4.0 is not just an update to existing practices — it’s a paradigm shift. It moves away from static, one-time validation toward a lifecycle-based, digital, and continuously assured model. By leveraging real-time data, integrated systems, and risk-based approaches, Validation 4.0 enables smarter decision-making, stronger compliance, and faster innovation.
This event will highlight the newly issued ISPE Best Practice Guide: Validation 4.0™ and explore how its principles can be practically applied in daily pharmaceutical operations (ISPE best practices guide Validation4.0).
What to expect
- Key Concepts – A clear introduction to the fundamentals of Validation 4.0, including a case study
- Interactive Workshop – Work in teams on a futuristic 3D “cell printer” case study.
Through process mapping and scenario-building, you’ll identify inefficiencies of paper-based systems, explore how to digitize validation, and design a 5-year roadmap toward continuous assurance — using a specific equipment example to make it tangible. - Expert Guidance on Digital Twins - Supported by Prof. Christoph Herwig (Körber Pharma), an expert in digital twins and bioprocess data science. At Körber Pharma — the company behind the leading PAS-X MES system and advanced data analytics solutions — he focuses on integrating digital technologies to improve process understanding, compliance, and lifecycle efficiency.
- Keynote Inspiration - Jörn Volckmann (FrontWell Solutions GmbH) will share his vision on the future of Pharma 4.0™ and Validation 4.0, offering motivation, direction, and some bold statements for the years ahead.
- Provocative Panel & Closing – We wrap up with reflections, Q&A, and challenging questions like “What if validation disappeared tomorrow?” to spark new perspectives.
- Walking Dinner with Music – End the day in the historic Poortgebouw with a gezellige networking dinner, music, and meaningful conversations with peers, sponsors, and speakers.
Who should attend
This event is designed for professionals in validation, quality, digitalization, and operations, as well as leaders driving Pharma 4.0™ initiatives. Whether you’re a validation specialist, digital transformation advocate, or simply curious about what Validation 4.0 could mean for your company, this day offers practical insights, networking, and inspiration.
Event Properties
| Event Date | 06-Nov-2025 13.00 |
| Event End Date | 06-Nov-2025 20.00 |
| Capacity | 100 |
| Registered | 88 |
| Individual Price | €95.00 |
| Location | Leiden, The Netherlands |
Agendas
| 13:00 - 13:30 |
Registration & Welcome CoffeeArrive early, collect your badge, and enjoy a coffee while meeting fellow participants, speakers, and sponsors. |
| 13:30 – 13:35 |
Opening RemarksModerator Michiel van Hoeven (Yxion) welcomes all participants and introduces the ISPE NL Pharma 4.0™ Community of Practice and today’s program. |
| 13:35 - 14:15 |
Validation 4.0: Where Are We Now?By Sana Ahmed A concise introduction to the principles of Validation 4.0, Process mapping, and how they align with Pharma 4.0™ transformation. |
| 14:15 - 14:45 |
Workshop I & II: The Challenge: Validating the Future Cell PrinterParticipants work in teams to explore a futuristic “cell printer” case, mapping processes and identifying challenges in moving from traditional to continuous validation. |
| 14:45 - 15:05 |
Poster Coffee BreakEnjoy coffee and explore short poster pitches by sponsors presenting innovative solutions in Pharma 4.0 and digital validation. |
| 15:05 - 15:30 |
Expert Input – Types, Applications, and Benefits of Digital Twins in Validation 4.0By Prof. Christoph Herwig (Körber Pharma) An inspiring insight into how digital twins support data-driven validation and continuous assurance. |
| 15:30 – 16:15 |
Workshop Phase III & IV – Building the Validation 4.0 RoadmapTeams integrate new data and insights to design their five-year digital validation roadmap. |
| 16:15 - 16:30 |
Workshop Phase V – Group ReflectionGroups finalize their concepts and prepare for the plenary discussion. |
| 16:30 – 17:00 |
Poster & Coffee BreakNetwork, visit the sponsor posters, and exchange ideas with peers and experts. |
| 17:00 – 17:30 |
Keynote – The Future of Validation 4.0By Jörn Volckmann (FrontWell Solutions) A forward-looking talk on the next evolution of Pharma 4.0™ and digital transformation in regulated environments. |
| 17:30 – 17:45 |
Closing Reflections & Q&AInteractive wrap-up with provocative closing questions like “What if validation disappeared tomorrow?” |
| 17:45 - 20:00 |
Walking Dinner & NetworkingRelax and connect over drinks, food, and music in the historic Poortgebouw — a perfect ending to a day of learning and inspiration. |
Speakers
Prof. Dr. Christoph Herwig
Founder Exputec, Sr Scientific Advisor
Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to enter his interdisciplinary PhD studies at EPFL, Switzerland in bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and facility design in biopharmaceutical industry. From 2008 to 2023, he wa full professor for biochemical engineering at the Vienna University of Technology. The research area focuses on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. In 2013 he founded the company Exputec, which is now part of Körber Pharma Austria, pioneering data science software solutions for the biopharma life cycle. Here, Christoph currently acts as senior scientific advisor for Körber.
Jörn Volckmann
Director
Expert in MES, Digital Manufacturing, and Validation 4.0 Jörn Volckmann is Director at FrontWell Solutions GmbH, where he advises life-science companies on strategies and implementations for Manufacturing Execution Systems (MES), Manufacturing IT, and Industry 4.0. With over 15 years of experience in digital manufacturing and IT system validation, he brings a deep understanding of how technology can create real value on the shop floor while maintaining compliance and efficiency. Before joining FrontWell, Jörn led Manufacturing IT and Automation initiatives at AbbVie Deutschland GmbH and served as Head of IT at Schott AG in the pharmaceutical packaging division. Since 2018, he has worked with Fresenius Netcare GmbH as Senior Project Manager and Manufacturing IT Expert, driving the digital transformation of production plants across the organization. At FrontWell Solutions, he continues to combine his technical and operational expertise to support clients in realizing Validation 4.0, MES integration, and Pharma 4.0 strategies that bridge IT, quality, and operations. His passion lies in empowering people on the shop floor through smart, compliant digital systems that simplify work and accelerate innovation.
Sana Ahmed
enterprise CSM
I specialize in leading digital transformation projects within the pharmaceutical and biotech industries, leveraging my expertise in process optimization, Quality by Design (QbD), and strategic implementation. With extensive experience in project management and cross-functional collaboration, I deliver tailored solutions that streamline CMC processes, enhance operational efficiency, and drive innovation. My background includes manufacturing/industrial roles across: • Cosmetic and pharmaceutical formulation laboratories. • Healthcare liquids and contained manufacturing facilities. • Microbiology and advanced continuous manufacturing systems. Currently, I empower scientists and technical teams to adopt and maximize the value of digital CMC platforms like QbDVision, aligning their operations with modern regulatory and industry standards. My approach combines technical expertise with strategic leadership to ensure impactful, scalable outcomes. I am passionate about bridging the gap between science and tech/AI, helping organizations achieve seamless implementation and long-term success in their digital journeys.
