Conducting Effective Investigations of Atypical and Out of Specification Laboratory Results (Laboratory Complianc)
Venue: Online Event
|Event Date/Time: Jul 19, 2012||End Date/Time: Jul 19, 2012|
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
- Evaluating the Outcomes: Is there an assignable cause?
- Documenting the Investigation.
- Utilizing Outcomes for Continuous Improvement.
- Questions and Discussions.