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Cleanroom Microbial Monitoring Cleanroom Microbial Monitoring Data for Actionable Insights to Meet and Exceed the Auditor’s Expectations

Effectively monitoring cleanroom microbial contamination has become more essential over the last year, especially with the upcoming release of EU GMP Annex 1. Modern pharmaceutical manufacturers are generating and managing big data from environmental monitoring; the next step is to create actionable insights and ensure 21 CFR Part 11 compliance. This on-demand webinar discusses:

  • cleanroom microbial monitoring data collection
  • 21 CFR Part 11 data management
  • generation of actionable insights

We will review how this is accomplished by leveraging industry standards such as the FDA/ICH guidelines that encourage the use of control charts as statistical tools to guarantee that a manufacturing process remains in a state of control (the validated state).

Attend this on-demand webinar to learn:

  • Critical microbial data management – Interpretations, considerations and solutions for data integrity, statistical control and FDA guidelines.
  • FDA and ICH guidelines and recommendations – How to leverage this information for better contamination control.
  • Data integrity – Definition and Inspectors’ perspective regarding environmental monitoring and data management, with attention to 21 CFR Part 11.
  • Elements to consider to ensure that a process is under statistical control.
  • The future of microbial monitoring in the Pharma industry – Benefits of single use microbial monitoring.

Complete the form here to access this on-demand webinar today. 

Looking for solutions to your Cleanroom Microbial Monitoring data management? Particle Measuring Systems has a full suite of options for you:

 

 

  • 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

    Paola Lazzeri

    EMEA Field Application Specialist Sterility Assurance/Microbiology, Particle Measuring Systems

    Paola has extensive professional experience over 14+ years supporting pharmaceutical companies in the application of regulatory requirements, with a specific focus on microbiological contamination control. She maintains this expertise through constant dialogue with Quality Officers, Production and Financial teams in the various industries she works with. She actively collaborates with the PMS Advisory Team on decontamination strategy using a Quality Risk Management approach and assists Pharma companies with the validation of sanitizing and decontaminating agents. Paola also regularly writes technical articles and participates as a speaker at national and international Pharma conferences.