Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results

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.
• Conducting the Investigation.
  • Creating an Investigation Checklist
  • Considering Other Batches
  • Retesting
• Evaluating the Outcomes:  Is there an assignable cause?
• Documenting the Investigation.
• Utilizing Outcomes for Continuous Improvement.
• Questions and Discussions.

Gregory Martin, is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources.