Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results

This 2-hr session will provide sound training on how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.

Why Should You Attend:

Upon completion of this course the attendee should:

  1. Be familiar with various terms associated with investigations of atypical or out of specification results, and how to document those investigations.
  2. Be familiar with the FDA Guidance for Industry on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production and how to apply it in laboratory situations.
  3. Be able to create a Laboratory Investigation Checklist and effectively document an investigation, including rationale and results.
  4. Know the importance of Corrective and Preventative Action (CAPA) and be able to identify appropriate CAPAs.
  5. Understand practical strategies to utilize outcomes from investigations for continuous improvement and reduction of future OOS results.

Areas Covered in the Seminar:

  • What Constitutes An Atypical or Out of Specification Result?
  • The Barr Decision of 1993 and Its Impact on OOS Investigations.
  • The FDA Guidance for Industry on Investigating OOS Test Results.
  • Reporting Data.