top of page
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.​

AdobeStock_388497162_edited.jpg
bottom of page