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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 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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