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On Demand | Duration: 60 min

Achieving EU GMP Annex 1 Compliance: Optimal Active Environmental Microbial Monitoring webinar now available on demand

There are several factors associated with active environmental microbial monitoring and a balance between these conditions results in the optimal performance of a Contamination Control Strategy. In this webinar, you will learn the requirements for monitoring of airborne microorganisms in controlled cleanroom environments. Additionally, you will learn the how to implement the requirements using portable devices with examples of typical applications within cleanrooms.

 

What you'll learn:
  • What the EU GMP Annex 1 and ISO/EN requirements are for active microbial monitoring.
  • The specific limits for monitoring.
  • How the collection mechanisms relate to each other for optimal performance
  • The types of equipment that could be used to meet the requirements.
Who should attend:
  • Quality Control Specialist
  • Validation Specialist
  • Production Teams
  • Environmental Monitoring Specialist
  • Microbiologist

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.

Giulia Artalli
Global Product Line Manager, Microbiology & Sterility

Giulia Artalli is Global Product Line Manager at Particle Measuring Systems, specializing in microbial environmental monitoring for pharmaceutical cleanrooms and GMP-regulated manufacturing. With over 20 years of experience in pharmaceutical microbiology, she advises global life sciences companies on contamination control strategies and regulatory compliance. Giulia’s background spans research and leadership roles at Becton Dickinson and Diversey, where she focused on microbiological risk mitigation in sterile production. She routinely educates cleanroom professionals on environmental monitoring best practices, Annex 1 updates, and microbial detection methods. Giulia brings a strong foundation in applying industry standards to viable particle monitoring programs. She presents internationally and contributes to Particle Measuring Systems’ global leadership in contamination monitoring for the life sciences industries.

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