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FIHomeWebinarsFilling the Gap in Sterility Testing: Traceability and 21 CFR Part 11 Compliance

Filling the Gap in Sterility Testing: Traceability and 21 CFR Part 11 Compliance



WEBINAR

Sterility Testing is part of a vast world of products and processes. Until now, a majority of results relied on written, post test recollections of the lab technician performing the test. Information regarding each test performed is critical during an investigation.

Imagine if you could use a system that would capture this information, verifying each of the steps, including the performance of the pump throughout the test, while remaining 21 CFR part 11 compliant.

We have a solution for you with our M-Trace® software!

The agenda:

  • An introduction to the M-Trace® system
  • A product demonstration
  • A live Q&A session

Join our product and services experts Yoann Mainguy and Benjamin Laichter for a one-hour webinar and discover how you can benefit from using our M-Trace® solution.

Speakers

Yoann Mainguy

Yoann Mainguy

Merck

Global Product Manager, Sterility Testing & Mycoplasma Testing

Yoann holds a degree in biology and biotechnology and has more than 20 years of experience in industrial microbiology. He has spent 15 years in different QA / QC roles in the Biomonitoring division of our company, covering our complete Pharmaceutical QC portfolio. In 2019, Yoann joined the Marketing organization as Product Manager for Sterility testing and Mycoplasma testing solutions, focusing on microbiology and quality control, including compendial, alternative and rapid methods. 

Benjamin Laichter

Benjamin Laichter

Merck

R&D Services Expert

Benjamin is a Service Expert within the Life Science’s BioMonitoring Research and Development Department. He is graduated from the University of Technology of Belfort-Montbeliard, France, with a Engineering degree in Electrical Engineering and Control System. For the past 8 years, he has been focusing on integration, validation, technical support and services development for qualified IT systems in the pharmaceutical and life sciences industries.

Webinar Information

Microbiological testing

  • Sterility testing
  • Duration:1h

  • Language:English

  • Session 1:presented May 21, 2024

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