Investigation of Out-Of-Specification Laboratory Results 2017

Topics

• The FDA model for handling OOS investigations
• Why the regulators are concerned about the handling of OOS investigations
• How the laboratory can meet regulatory expectations for OOS investigations
• Commonly accepted terminology such as repeat testing and retesting
• The interaction between the laboratory and other units in the organization

Who should Attend

• Laboratory Analysts
• Laboratory Supervisors
• Quality Assurance Record Reviewers
• Quality Assurance Managers