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.
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.
Aprende de los mejores
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.
Division 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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¿Es para ti?
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
Sigue viendo
Webinar On DemandDurante este webinar, aprenderás a preparar eficazmente un sistema de gestión de calidad ATMP conforme. Descubre los elementos clave necesarios para establecer y mantener un SGC que cumpla con las regulaciones de Eudralex Parte IV.
Ver ahora
Webinar On DemandEn este webinar nos adentramos en el fascinante mundo de la cadena de suministro de ATMP (Advanced Therapy Medicinal Products). Descubre cómo superar los principales retos a los que se enfrentan los líderes de la industria y obtén información fascinante sobre la innovadora estrategia «vena a vena». A través de ejemplos y elementos visuales reales, exploraremos la hoja de ruta para navegar por la cadena de suministro de ATMP y liberar todo su potencial.
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