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On Demand

Environmental Monitoring as a Component of a Contamination Control Strategy

The implementation of a Contamination Control Strategy (CCS) requires a technical and process understanding of the potential sources of contamination. The role of Environmental Monitoring as a Component of a Contamination Control Strategy is essential to successfully attain that goal.

In this introductory webinar we review those elements of an environmental system to be considered within a documented CCS:

-Process risk assessment.

-Monitoring systems – including an assessment of the feasibility of the introduction of scientifically sound, modern methods that optimize the detection of environmental contamination.

-Prevention – trending, investigation, corrective and preventive actions (CAPA), root cause determination, and the need for more comprehensive investigational tools.

and finally continuous improvement based on information derived from the above.

Who should attend this webinar:

All Pharmaceutical cleanroom users, especially those working in the following departments;

  • Quality Assurance
  • Quality Control
  • Information Technology
  • Engineering
  • Production
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.

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