From Regulatory Expectations to Practical Remediation
This webinar translates the revised EU GMP Annex 1 requirements into structured, practical actions across sterile manufacturing environments. Learn how to assess implementation challenges, prioritize remediation efforts and strengthen sustainable compliance.
Contents
QbD Group helps pharma and biotech manufacturers strengthen manufacturing performance through integrated quality, compliance, and operational expertise, keeping sites efficient, compliant, and inspection-ready.
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.
向最优秀的人学习
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.
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.
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.
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