Laboratory Investigation Out-of-Specification Results 2016

Topics

• The guidance process
• What constitutes an OOS observation
• The initial laboratory investigation
• Steps to be taken in the laboratory in the event of an OOS observation
• Retesting
• Repeat testing
• Reporting the investigation to Quality Assurance
• Confirmation of the OOS Observation

Who should Attend

• Quality Assurance Managers, Supervisors and Reviewers
• Quality Control Managers, Supervisors, Reviewers and Analysts