GoingToMeet

This course is focused on production process deviation investigation, which happens frequently in pharmaceutical and biopharmaceutical manufacturing. The deviation requires thorough investigation to determine the root and probable causes. The potential impact of the deviation on product quality should be assessed. Corrective/preventive actions should be implemented to prevent repeat occurrences of the deviation. A comprehensive and thorough understanding of 1) the nature of deviation, 2) how to plan and conduct investigation and 3) how to assess product impact by the deviation, is essential for investigators and other members in the investigation team (i.e. production, engineering, QA, QC, and RA). This course will detail the planning strategies in investigation of production process deviation. Investigation techniques and product impact assessment will also be discussed. Managing a complex investigation in a timely manner is a major task. The class will also cover how to effectively manage and conduct a thorough investigation. Effectiveness evaluation of CAPA as a result of an investigation will also be discussed. Actual case studies will show how investigations are conducted to prevent deviations from happening again.