Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations
: 9 Dec 2020
This live training webinar will discuss laboratory deficiencies and how to minimize OOS and OOT investigations. It will discuss CAPA and how ruggedness must be built into the analytical procedure to prevent OOS occurrences. It will also cover performance metrics as well as discuss the key performance indicators through metrics, so system performance can be determined.
- Review regulatory deficiencies to establish an investigation process.
- Build ruggedness into the analytical procedures to prevent OOS occurrences.
- Build compliance into the investigation process to minimize OOS.
- Determine Key Performance Indicators (KPI) to monitor a process.
- Establish documentation and performance metrics.
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Auditor Professionals
- Regulatory Affairs Professionals