Contamination Control in Sterile Manufacturing: Bridging the Gap Between Annex 1 Expectations and Reality

This 4-session webinar provides a comprehensive, practitioner-led exploration of contamination control in sterile and aseptic pharmaceutical manufacturing. The programme spans environmental monitoring design, contamination control strategy development, excursion investigation, aseptic behaviour, and regulatory inspection readiness under EU GMP Annex 1 (2023). Each session is designed to stand alone but together forms a complete learning journey — from foundational monitoring principles through to inspection-ready quality system documentation.

Contamination control in sterile manufacturing has undergone a fundamental shift in regulatory expectation. EU GMP Annex 1 (2023 revision) requires manufacturers to demonstrate not just that monitoring programmes are in place, but that they are embedded in a living, risk-based Contamination Control Strategy that drives operational decisions and quality culture.

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This webinar delivers a practitioner-led journey through the critical dimensions of contamination control — from programme design and data trending to excursion management, aseptic behaviour, and inspection readiness. Speakers bring direct experience from regulated sterile manufacturing environments, ensuring every session delivers tools and frameworks applicable in your organisation.

This webinar has been developed for professionals working in or intersecting with GMP-regulated sterile and aseptic pharmaceutical manufacturing environments who are responsible for contamination control, quality assurance, environmental monitoring, or regulatory compliance and is is equally valuable for professionals at pharmaceutical manufacturers, biologic and ATMP developers, CDMOs, CROs, and engineering consultancies operating under EU GMP and FDA regulatory frameworks.