Webinar | EU GMP Annex 1 Implementation: From Regulatory Expectations to Practical Remediation

The revised EU GMP Annex 1 represents one of the most significant regulatory updates for sterile manufacturing in recent years. Beyond interpretation, authorities now expect demonstrable, fact & risk-based and sustainable implementation across facilities, utilities, quality systems and contamination control strategies. "Risk"-based arguments for not being compliant are not accepted anymore.

This webinar provides a structured approach to Annex 1 readiness and remediation. Our experts will explore the historical evolution of Annex 1, analyze the practical challenges manufacturers face, and focus on critical remediation areas frequently linked to inspection findings.

Drawing on regulatory trends and insights from FDA warning letters, the session connects regulatory expectations with real-world implementation strategies to support decision-making at site level.

What you'll learn

• How Annex 1 evolved and why its implementation requires a cross-functional, risk-based approach
• How to identify and prioritize remediation areas based on inspection trends, time for implementation and operational risk
• What regulators expect in the most critical implementation areas under Annex 1
• What FDA warning letters reveal about Annex 1 readiness and recurring non-conformities
• How to structure a practical remediation roadmap aligned with sustainable compliance

Speakers

This session brings together decades of hands-on experience in sterile manufacturing, GMP compliance, and contamination control strategy. Our speakers combine deep technical expertise with regulatory insight gained from global leadership roles at organizations including Alcon, Novartis, and Sandoz — offering practical guidance you can apply directly to your Annex 1 remediation journey.

- Jo Doucet: Global Head Qualification & Validation, QbD Group
- Geert Vandenbossche: Founder & Owner, C&E Solutions