Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results 2017 is a webinar that covers topics such as:
- The Barr Decision of 1993 and its impact on OOS investigations
- What constitutes an atypical or Out of Specification result?
- Reporting data
- The FDA guidance for industry on investigating OOS test results
- Creating an investigation checklist
- Conducting the investigation
- Retesting
- Considering other batches
- Documenting the investigation
- Evaluating the outcomes: Is there an assignable cause?
- Utilizing outcomes for continuous improvement
Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results 2017 is intended for:
- Supervisors and Managers
- Chemists
- GMP auditors
- Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment
- Regulatory Affairs
- Analysts and other laboratory staff
- Product Development Analysts
- Product Development analytical testing Managers and Directors
- Quality Assurance Directors, Managers and record reviewers