Webinar: Pharma 4.0 – The Digitalization of the Holistic Control Strategy Concept based on ICH Q10

The Future of Pharma is Here – and We’re Leading the Way!

We are thrilled to announce the launch of the ISPE Netherlands Community of Practice (CoP) for Pharma 4.0, a new initiative designed to drive innovation and knowledge sharing in digital transformation for the pharmaceutical industry.

What’s Our Mission?
To create an open and collaborative platform for professionals passionate about the integration of digital technologies, data-driven insights, and next-gen manufacturing principles. Whether you're an expert in Pharma 4.0 or just curious about how digital transformation is shaping our industry, this is your chance to connect, learn, and grow.

Lunch Talk Series 2025 (MS Teams)
Join us for our 3rd monthly lunch talks, starting April 17th. 

The pharmaceutical industry is in the midst of a digital transformation, moving from a process-centric to a data-centric approach. Pharma 4.0™ is not just about automation—it’s about ensuring real-time transparency, regulatory alignment, and operational efficiency across the entire product lifecycle.

In this 30-minute session, Christian Woebeling, a key contributor to the ISPE Pharma 4.0™ Special Interest Group, will explore:

✅ How emerging technologies can make pharmaceutical manufacturing more robust, flexible, and resilient to disruptions
✅ The Pharma 4.0™ holistic control strategy—a digital-first approach to implementing ICH Q8-Q12 for quality control and continuous improvement
✅ How to transition from traditional siloed, experience-based decision-making to a fully integrated, data-driven operating model
✅ Real-world case studies of companies implementing holistic digital control strategies

Registration on webinar link: Microsoft Virtual Events Powered by Teams

The event is sponsored by Adryan

Why Join Us?

• Learn: Gain insights into Pharma 4.0 principles and applications.
• Connect: Network with like-minded professionals in the pharmaceutical industry.
• Grow: Be part of a community shaping the future of pharma manufacturing.

Speaker bio - Christian Woelbeling

Christian Woelbeling is Executive Industry Advisor & Senior Strategic Account Manager Software at Körber Business Area Pharma, based in Lüneburg, Germany.

Christian holds a Master Degree in Mechanical Engineering. For over 33 years working in Life Sciences Manufacturing IT, Christian has great experience in all GMP-related processes. He is actively involved in the ISPE, e.g. as Founder & Leader of the Community of Practice / CoP “Pharma 4.0”, ISPE “Advancing Pharmaceutical Quality” APQ Core Team Member, “PAT & Lifecycle Control Strategy” CoP Past Chair & Steering Member, and ISPE Affiliate DACH Board Member. Christian was named a “Pharma Industry Leader” by the ISPE Pharmaceutical Engineering Magazine in 2020. He is one of the lead authors of the ISPE Pharma 4.0 Baseline Guide and ISPE APQ Guide “Process Performance & Product Quality Monitoring System / PP&PQMS”.

Synopsis – The Digitalization of the Holistic Control Strategy Concept based on ICH Q10
Pharma 4.0™ is transforming pharmaceutical manufacturing by integrating digitalization into quality control and operational processes. In this session, Christian Woebeling will explore how the holistic control strategy, based on ICH Q8-Q12, enables real-time data utilization, automation, and continuous improvement. The shift from manual, experience-based decision-making to data-driven transparency is essential to overcoming inefficiencies and ensuring product quality. By leveraging emerging technologies, companies can strengthen their supply chains, reduce production disruptions, and enhance regulatory compliance. This talk will provide practical insights and real-world case studies demonstrating successful digital transformations. Join us to discover how Pharma 4.0™ is shaping the future of pharmaceutical manufacturing.

Format:

30 min Presentation – Insights into emerging trends and case studies
30 min Discussion – Open dialogue on challenges, opportunities, and future directions