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 the Life Sciences Global Manager and Senior GMP Advisor at Particle Measuring Systems. Over Mark’s long career in contamination control, he has managed the design, installation, and validation of over 200 environmental monitoring system projects worldwide. He has designed several products specific for pharmaceutical environmental monitoring, including particle counters for explosive and corrosive areas and 21 CFR part 11 compliant software for batch test and release. He currently lectures for the PDA, ISPE, and other international pharmaceutical societies on environmental monitoring and GMP compliance design and validation. Mark has written over 100 technical papers on environmental monitoring and contributed to several books specific to this field. Most recently, Mark was a member of the international ISO 14644-21 technical committee responsible for reviewing and revising the standard. He was awarded the IEST James Mildon award for “significant contributions to the advancement and increase of knowledge in the field of contamination control”.