This eLearning module is designed to provide essential training for conducting Out of Specification (OOS) investigations in GMP environments.
|Who is it for||
This course recommended for all levels of technical staff and managerial personnel dealing with OOS results, including analytical laboratories, contract laboratories, and QA and QC personnel.
|Why it matters||
While the FDA and MHRA have published guidance about it, the investigation of OOS results continues to be a much-debated topic during FDA inspections. The incorrect handling and investigation of OOS results are still frequently cited in Warning Letters Understanding how to identify a true OOS from other types of Laboratory investigations (ex: Invalid Assays, Known Lab Error, Atypical Events or a Lab Calibration out of Tolerance) as well as when to perform a retest based on the findings of the OOS investigation is critical to achieving compliance.