This webinar addresses the adequate investigation of deviations, an area that is receiving FDA attention as evidenced by citations in Warning Letters and 483 observations.
Areas Covered in the Seminar:
Who Will Benefit:
- What should be investigated - Complaints, audit observations, deviations, discrepancies, calibration out-of-tolerances.
- FDA expectations for investigations.
- The investigation-problem resolution process - understand the problem, identify possible causes, data collection, data analysis, root cause identification, root cause elimination, solution implementation, verify success.
- Tools for understanding the process - mapping, critical incident, performance matrix.
- Tools for understanding the possible causes - brainstorming, is/is not, nominal group.
- Tools for narrowing the investigation to the most probable cause - data collection, data analysis.
- Determining the root cause - cause and effect, Fault tree, 5 Whys.
- Corrective action.
- Preventive Action.
- QA document reviewers
- QA personnel responsible for reviewing investigations reports
- QA personnel responsible for the deviation and investigations systems
- Quality and Operations personnel responsible for investigations
- Personnel from all units responsible for initiating investigations
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