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Duration: 60 min
When? October 21, 2024
Time options:

Achieving EU GMP Annex 1 Compliance: Optimal Active Environmental Microbial Monitoring free webinar on October 21st

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

Duration: 60 min
When? October 21, 2024
Time options:
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”.

Giulia Artalli
Global Product Line Manager, Microbiology & Sterility

Giulia Artalli is experienced in pharmaceutical microbiology and is currently Global Product Line Manager at Particle Measuring Systems. She started her career in research, before moving to work for companies such as Becton Dickinson and Diversey with a specific focus on the Life Science market. Giulia has extensive professional experience over 20+ years supporting pharmaceutical companies in the application of regulatory requirements, with a specific focus on microbiological contamination control. In her current role, she is focused on microbial environmental monitoring and supporting customers in the correct application in compliance with regulatory specifications.