Microbiology for Compliance Teams

Course outline An understanding of microbiology is essential for all sterile medical device manufacturers. This new course opens up the subject to non-microbiologists, removing the mystique and explaining the key concepts and terminology you need to know. As well as clarifying the types and nuances of microbiology testing, it explores the sources and types of microorganisms typically found on medical devices and within cleanrooms, and shows their implications for your organisation and devices. Among the types of microbiology testing we look at are bioburden testing and sterility testing, explaining the different types of testing; how to determine an appropriate Sterility Assurance Level (SAL); the importance of compliance with the ISO 11737-1 and ISO 11737-2 standards; and how to demonstrate that in your own organisation. We also take you through the different types of environmental monitoring, so you can effectively monitor a cleanroom environment. By the end of the course, microbiology will appear far less daunting, and also far more important.

Topics covered include:

  • Explanation of the key concepts in microbiology including understanding the terminology and definitions
  • Different types of microorganisms that may be encountered and their significance
  • Explanation of the different microbiology tests used in the medical device including cleanroom monitoring
  • Expectations of the regulatory authorities with respect to microbiology testing and ongoing controls
  • Setting microbiological limits and looking at the key issues for investigating out of specification results
  • Understanding the importance of microbiological control for medical devices and the impact this can have on the sterilisation process

Course Outcomes
At the end of the course, delegates will gain an understanding of:

  • Basic Microbiology
  • Microbiological terms and definitions
  • Bioburden testing
  • Sterility testing
  • Environmental monitoring for Cleanrooms
  • Setting limits and trending
  • Aspects of Microbiological Investigations
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