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The Annex 1 Draft and a New Single Use Monitoring Solution

The purpose of this webinar is to show the main points of the Annex 1 draft regarding the new monitoring technologies approach. We highlight the benefits of Single Use Systems applied to microbial active air sampling and how it is possible to use in place of traditional methods like settle plates and focus on Particle Measuring Systems’ BioCapt® Single Use impactor.

We cover:

  • how to perform the PQ2 and
  • validation of this product
  • as well as the evaluation of ROI when a single use technology is implemented.
  • Presenter

    Giulia Artalli

    Global Product Line Manager, Particle Measuring Systems

    Dr. Artalli has a degree in biology from the University of Milan with over 20 years’ experience in Microbiology, specifically for pharmaceutical applications.
    Dr. Artalli has covered different roles acquiring knowledge on different topics useful for supporting customers in their needs; she is a Global Product Line Manager at Particle Measuring Systems for the Microbiology product line.

  • Presenter

    Ugonna Omeronyé

    Global Pharma GMP Advisory Specialist

    Ugo has worked with pharmaceutical companies to support quality assurance and control. She is especially skilled in data-driven corrective and preventative actions for environmental monitoring and contamination-control strategies affecting medical devices and drug production. Ugo earned her Master’s in Biomedical Sciences; focusing on pharmacology, validation methodologies, and technologies to effectively streamline sterile manufacturing.