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Handling Out-of-Specification (OOS) Events
  • 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.​

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