Branch chief, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER US FDA Silver Spring, Maryland
In this session, the topics such as integrated quality assessment for process and facilities will be covered. Review and inspection considerations utilizing risk based approaches will be discussed. Failure Mode and Effect analysis (FMEA) principles have been utilized to assess initial risk for manufacturing which will be presented and risk mitigation approaches will be discussed. Case studies also will be included to explain the concepts presented for structured manufacturing assessment.