Pharma
Transforming Contamination Control from a Compliance Activity into Operational Excellence
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.
Read moreTransforming Contamination Control from a Compliance Activity into Operational Excellence
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.
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.
Understand EU GMP Annex 1 (2023) requirements and translate them into compliant quality systems and audit-ready CCS documentation.
Gain clarity on how regulators are currently interpreting contamination control requirements and what inspection evidence is expected.
Design and justify a risk-based environmental monitoring programme with defensible alert and action limits aligned to Annex 1 (2023).
Understand contamination risk management in isolator and RABS environments, including personnel behaviour and intervention protocols.
Build qualification packages for contamination control systems that withstand regulatory scrutiny under Annex 1 (2023).
Build strategic oversight across contamination control to support informed decisions on programme investment and inspection readiness.
This webinar 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.
The Early Bird Offer expires in 30 days!
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The Early Bird Offer expires in 30 days!
Managing Director and Consultant with Paradigm Pharmaceutical Quality Consultancy (PPQC). Quality professional with a Microbiology & Sterile Manufacturing background with 30 years’ experience in the Pharmaceutical Industry. Holding a Master Degree in Pharmaceutical Microbiology form the University of Manchester. Worked for several global Pharmaceutical and Biotechnology companies in different Quality roles working with a variety of platforms including Biologics, ATMPs, Sterile Fill Finish and Solid Oral Dose.
Involved with several site and laboratory expansion projects from construction design through to method transfer and operational readiness, and has provided Quality, Sterility Assurance and Microbiology oversight where relevant during these projects.
Lead auditor conducting audits and have been involved with audits facing several competent authority inspections including but not limited to the HPRA, FDA, ANVISA, Chinese FDA and Canadian Health Authority inspections.
Risk facilitator for Quality Risk Management programs and significant experience with problem-solving and management of complex investigations. Co- author of the PDA Technical Report 90 for “Contamination Control Strategy” and Edufarma’s education program “Farmaceutisch Vakman (Pharmaceutical Professional).
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