Annex 1 in Practice: Field-Tested Answers for Today's Implementation Challenges

    Field-Tested Answers for Today's Implementation Challenges

    🕐 3 PM CET

    This session is built directly on structured feedback gathered from pharmaceutical manufacturing professionals on where they need more practical depth. Rather than reintroducing Annex 1 concepts, our experts go straight into execution, focusing on the areas that matter most in day-to-day implementation.

    Annex 1 implementation does not stop at the initial risk assessment or the first CCS draft. It lives in the ongoing decisions manufacturing and quality teams make every day: how often to revisit the CCS, how to approach single-use components without losing control over contamination risk, and which filter or monitoring strategy actually fits a given zone classification.

    This webinar walks through these areas in full, so attendees leave with a complete, practical picture rather than a single recommendation.

    Agenda

    Live presentation + Q&A, with live chat and polls

    What You'll Learn

    • How to define and defend a CCS review cadence, ownership model and update triggers that hold up under inspection
    • How to approach single-use components under Annex 1 without compromising contamination control
    • What to check before, during, and after implementation to keep a single-use setup inspection-ready
    • The full range of approaches to filter strategy and zone monitoring, including PUPSIT with multiple filters and tightened LAF/GAAS/Grade A monitoring, and how to weigh them for your facility
    • How manufacturing peers across the industry are approaching these same decisions today

    Speakers

    Two QbD Group qualification and validation experts bring hands-on Annex 1 remediation experience from sterile manufacturing sites across Europe.

    Jo Doucet

    Global Head Qualification & Validation

    Qualification & Validation, QbD Group

    Jo 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.

    Stan Van Kerkhoven

    Senior Project Manager Qualification & Validation

    Qualification & Validation, QbD Group

    Stan is a Senior Project Manager at QbD Group, leading Annex 1 gap assessments, contamination control strategy programs and cleanroom qualification projects for sterile manufacturing sites.

    Who Should Attend

    This session is built for manufacturing, quality and engineering teams responsible for translating Annex 1 requirements into daily practice.

    • Site Heads and Plant Managers accountable for sterile manufacturing compliance
    • Heads of Manufacturing and Operations Directors driving remediation planning and execution
    • Quality Directors and QA Managers owning the contamination control strategy
    • Engineering, Validation and Technical Operations Leads designing filter and monitoring strategies
    • Cross-functional teams responsible for CCS, remediation planning and execution