Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results 2017

Topics

• 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

Who should Attend

• 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