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Quality CoP Kick-Off Webinar: Advancing Quality Thinking

We are proud to officially launch the ISPE NL Quality Communitv of Practice - a new forum for life sciences professionals to strengthen knowledge, connect expertise, and collaborate on the future of pharmaceutical quality.

To mark this milestone, we invite you to our first community event.

Date: 21 Januarv 2026

Time: 12:00-13:00 CET

Speaker: Astrid Bulsink

Format: webinar

Advancing Quality Thinking: The New Focus on Risk Management, Data Integrity & Process Understanding

Recent proposed updates to Eudralex Volume 4 - ncluding Chapter 1, Chapter 4, Annex 11 and the ntroduction of Annex 22 on Artificial Intelliaence - reflect a rapidly evolving GxP landscape driven by automation, digitalisation and data integrity needs.

As technology accelerates, quality professionals must not only comply - but think, interpret and lead.

In this session, we will explore:

- What links the current regulatory revisions

- Why QRM is more than identifying risks

- How expected Data Integrity maturity is changinc

- The growing need for product & process understanding

Why knowledge management and culture matter The role of senior leadership in next-generation Quality systems.

This webinar marks the beginning of many activities from the new CoP - a community dedicated ta pioneering Quality thinking in the Netherlands and beyond, together with DARQA and NIA - Vereniging var Nederlandse Industrie-Apothekers

Register here: https://ispe-events.us3.list-manage.com/track/click?u=f8430f240063bbae2d9a89ecd&id=931a59ab20&e=72d7f6ac39

Acknowledgement to QbD Group for technical support of this webinar.

We look forward to seeing you at the launch - and to building this strong Quality network with you.

URS & Risk Assessment: The Foundation for Successful Engineering

A well-defined User Requirements Specification (URS) and a thorough Risk Assessment form the foundation of successful projects within the pharmaceutical industry. But how can you ensure that requirements, engineering, and quality are aligned from the very beginning?

During this event, organised as a collaboration between the CQV Community of Practice and the Quality Community of Practice of ISPE, we will explore the connection between engineering, quality, and risk management.

The event will focus on the practical application of developing an effective URS and performing risk assessments within pharmaceutical projects. We will discuss how a risk-based approach can support better decision-making, create clearer requirements, and contribute to more efficient engineering and quality processes.

This event is aimed at professionals at all levels working in the pharmaceutical industry who have an interest in engineering, quality, commissioning & qualification, validation, and risk assessments. It provides an excellent opportunity to exchange knowledge and experiences and to bring together different perspectives from both engineering and quality.

Join us for an inspiring and interactive event where practical experience, knowledge sharing, and collaboration take centre stage.