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

    📅 Date: 30 April, 2026 🕐 Time: 4 PM CEST / 2 PM GMT 🏷️ Topic: Quality Assurance, GMP Compliance 🌐 Language: English

    About this webinar

    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

    Jo Doucet is an expert in qualification and validation with over 20 years of experience in the pharmaceutical industry. He leads the Qualification/Validation division at QbD Group, supporting teams and clients in GxP compliance projects across manufacturing, IT, QC, and medical devices.

    Geert Vandenbossche, PhD

    Founder & Owner, C&E Solutions

    Geert brings 30 years of senior leadership experience from Alcon/Novartis across both global and site roles. As Global Head of Engineering and MS&T, he successfully integrated the Advanced Accelerator Applications start-up into the Novartis Radioligand Therapy unit. Earlier, Geert served as Global Head of Quality for all Sandoz Sterile and for Novartis Biologic sites, leading Global Quality Strategic Initiatives with a key focus on Annex-1 aseptic processing.

    Who Should Attend

    This webinar is ideal for professionals working in sterile manufacturing and GMP compliance.

    • Site Heads and Plant Managers
    • Heads of Manufacturing and Operations Directors
    • Quality Directors and QA Managers
    • Engineering, Validation and Technical Operations Leads
    • Cross-functional teams responsible for CCS, remediation planning and execution