Webinar: Review of Annex 1 2022: Environmental Monitoring Changes

On Demand

Review of Annex 1 2022: Environmental Monitoring Changes

The long-anticipated revisions to EU GMP Annex 1 have officially been implemented, leaving many manufacturers navigating the complexities of compliance. To help you stay ahead, Particle Measuring Systems (PMS) has enlisted two of our leading experts to clarify the updated environmental monitoring requirements, provide practical solutions, and answer your most pressing questions.

With a shift toward strategic control rather than simple quality measurement, the latest Annex 1 emphasizes Quality by Design (QbD) and a risk-based approach. This interconnected strategy ensures that cleanroom classifications are maintained and that environmental monitoring is directly aligned with product protection.

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What you'll learn:

How the Annex 1 layout has evolved for controlled environments
Key changes in cleanroom classification
New and enhanced approaches to cleanroom monitoring

Don’t miss this opportunity to strengthen your contamination control strategy and stay fully compliant in 2025.

Webinar Presented By:

Mark Hallworth

Global Pharma and Sr. GMP Advisor, Life Sciences Division

Mark Hallworth is a globally recognized authority in pharmaceutical contamination control, specializing in the design, validation, and implementation of GMP-compliant environmental monitoring systems. With decades of experience, he has led more than 200 projects across cleanroom facilities, focusing on regulatory compliance, data integrity, and system performance. Mark has contributed to the development of particle counters for hazardous environments and 21 CFR Part 11–compliant software for batch release and test management. He has authored over 100 technical papers and contributed to leading industry publications and reference books. Mark frequently presents at international forums, including the Parenteral Drug Association (PDA) and ISPE, where he teaches best practices in cleanroom monitoring and GMP compliance. Additionally, Mark served on the ISO 14644-21 technical committee and received the IEST James Mildon Award for advancing knowledge in contamination control. His work continues to shape standards and practices across the global pharmaceutical and biotechnology industries.