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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 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”.