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.