Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results 2018

Topics

• Gauging the impact of OOS results
• Review of recent FDA Warning Letters regarding OOS results
• Initiating an Investigation
• Get familiar with The FDA Guidance for Industry on Investigating OOS Test Results and the terminology inspectors will use
• Conducting the Investigation
• EXERCISE: Assess several examples to evaluate how much work is necessary
• Evaluating the Outcomes: Were you effective in identifying the real problem (root cause)?
• Documenting the Investigation
• CAPA
• EXERCISE: Discuss your challenging investigations and get feedback from the instructor and attendees

Who should Attend

• Chemists
• Supervisors and Managers in Pharmaceutical (Human or Veterinary)
• Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment
• Generic, OTC or Contract Laboratories