Handling Out-of-Specification (OOS) Events
This eLearning module is designed to provide essential training for conducting Out of Specification (OOS) investigations in GMP environments.
Overview of industry guidance for Out of Specification (OOS) Investigations
Types of OOS events
Repeated Testing, Retesting, reporting of results
Phases of OOS investigation: Phase 1a, 1b, 2a, 2b and phase 3
Key responsibilities of analysts, supervisors and managers in OOS investigation
FDA warning letters related to OOS
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 FDA 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.
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.
