The course explores the process for investigation of OOS results and the different phases of investigation, and also best practice investigation skills for effective and scientific OOS investigations. This includes:
- Following a scientific rationale,
- The expectations of regulatory authorities,
- Gathering available evidence,
- Generating potential hypotheses,
- Testing those hypotheses,
- Interpretation of hypotheses testing using appropriate statistical tools,
- Performing root cause analysis, using appropriate and effective tools and techniques.
The course is aimed at the investigation of all out of expectation (OOE) results, including out of specification (OOS), out of trend (OOT) and any atypical, aberrant or anomalous results. For convenience, the term OOS is used in the following information, but all OOE results will be covered in the course.
Attendees are invited to bring along any real life examples that they would like advice on during the training. These may be discussed during group exercises, or, where intellectual property is an issue, privately with the trainer.
Total learning time = 7 hours
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