This Pharmaceutical training provides guidance to the pharmaceutical industry pertaining to the investigation process for occurrences where laboratory results fall outside of specification limits.
In October 2006, the FDA released the OOS final guidance document entitled Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production. This document provides guidance to the pharmaceutical industry pertaining to the investigation process for occurrences where laboratory results fall outside of specification limits. Due to controversies and much discussion, this new guidance replaced the draft guidance from September 1998.
In October 2006, the FDA released the OOS final guidance document entitled Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production. This document provides guidance to the pharmaceutical industry pertaining to the investigation process for occurrences where laboratory results fall outside of specification limits. Due to controversies and much discussion, this new guidance replaced the draft guidance from September 1998.
Areas Covered in the seminar:
- Requirements for investigating OOS results in the laboratory area.
- Responsibilities of the analyst and supervisor.
- Extension of the investigation to manufacturing processes and raw materials.
- Discuss the interpretation of investigational results.
- Quality Control Unit responsibilities when concluding the investigation process.
Who Will Benefit:
This webinar will provide direction to all regulated companies that need to comply with FDA’s OOS final guidance document entitled Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.- Managers
- Supervisors
- Associates
- Quality Assurance
- Quality Control
- Compliance and Manufacturing
Course Provider
Michelle Sceppa,
