Screenshot of a sky blue background.

Pharmaceuticals, Medical Devices

Resolving Out Of Specification Test Results

About the Course

Obtaining an out of specification test result can be unsettling, and it is important that you know what to do with it. In this online training course, you will learn what the FDA says about handling batch or product samples that indicate out of specification results. You will also learn how to evaluate suspect results as well as how to conduct preliminary investigations in response to OOS results. This eLearning lesson will provide you with the information to respond accordingly when an OOS result is encountered. Mastering this regulatory compliance content will enable you to know what to look for and what to investigate when an OOS result occurs. The training will also explain the cautions involved in handling data that may be related to OOS results, such as re-testing, averaging, and outliers.