Consumer Safety Officer, Special Assistant, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII) FDA (Invited)
Verification and Validation of Manufacturing Processes: Hear from FDA investigators about how to decide if a process requires validation and best practices for conducting validations. This breakout session will go through case studies of manufacturing process validation, discuss risk-based decision making and how it applies to verification & validation, and de-mystify attendees understanding of when verification is acceptable and when a full validation is required.
