How to Investigate Environmental Monitoring Excursions

This OOS investigation training will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions.

Why Should You Attend:

Medical products are manufactured in environments that control the level of viable and non-viable particulate and to establish that the control is taking place periodic monitoring must be performed. But any time monitoring occurs there is the potential that the results will exceed limits that have been established. The action to be taken when this occurs should be appropriate and designed to determine the cause of the limit excursion. Knowing what is appropriate is important to ensure that the investigation is performed effectively.

This presentation will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions. It will also offer some guidance on how to establish or re-establish limits that are appropriate to the specific manufacturing process. There will also be discussions on how to document the results of the investigation.