Annex 1 Environmental Monitoring Common Questions and Answers

On Demand

The newly published Annex 1 comes into effect this August 2023, Particle Measuring Systems have been involved in discussions with industry and regulatory focused teams defining how best to address the new elements of environmental monitoring to meet these new requirements.

Environmental Monitoring expert Mark Hallworth shares questions he frequently receives, along with practical answers to help you meet your EM needs.

This webinar covers:

Certification vs monitoring
Tubing length and particle losses
Appropriate alert and action limits
Continuous microbial sampling using RMM and traditional techniques

Who should attend:

Environmental Monitoring team members
Quality Assurance
Quality Control
Production Team Supervisors

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.