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

We are proud to launch the ISPE Netherlands Quality Community of Practice (CoP) — a new professional community dedicated to strengthening pharmaceutical quality practice across the full product lifecycle. To mark this milestone, the Quality CoP invites members and interested professionals to its first webinar:

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

Over the past year, several important updates have been proposed to Eudralex Volume 4 — including Chapter 1 (Pharmaceutical Quality System), Chapter 4 (Documentation), Annex 11 (Computerized Systems) and the introduction of Annex 22 on Artificial Intelligence. These developments reflect the accelerating integration of digitalization, automation and data-driven technologies in GMP environments.

This session will explore what these changes mean in practice — and why now, more than ever, quality professionals are expected to think, interpret, and apply knowledge proactively, rather than rely solely on prescriptive guidance.

Key discussion points:

• What ties the current regulatory revisions together

• Why Quality Risk Management is more than just identifying risks

• How Data Integrity expectations are evolving for hybrid and automated systems

• The growing roles of product & process understanding and knowledge management

• The essential involvement of senior leadership in shaping quality culture

This is the first of many topics that will be covered by our new ISPE NL Quality CoP — and we look forward to building this community with you.