Bioburden Alert and Action Levels - Low Hanging Fruit for an FDA Citation

Most medical device industry standards for bioburden and related environmental testing (e.g., ISO 11737 1 8.6 and ISO 11137-2 10.1) refer to establishing alert and action levels. They may include guidance, which must be flexible and therefore lack details. This webinar can help by providing you with a foundation for setting alert and action levels. It includes common practices, different approaches, and suggestions for bioburden excursion actions.