Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results 2018 covers topics such as:
- 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
Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results 2018 brings together:
- 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