Enhance your understanding of process validation and how it is applied to the development of medical products. Learn how to assess an appropriate level of process scrutiny to provide a high level of confidence for process validation. Increase your knowledge of validation project management; basic approach to process validation; validation criteria for facilities and utilities; sterilization; controls, automated processes, and computer systems. Case studies illustrate how critical processes are validated in the development of cardiovascular, ophthalmic, and intravenous devices.
Prerequisite: Eecs X445.2, Regulatory Requirements for Medical Devices or Eecs X445.26, Regulatory Requirements for Pharmaceuiticals; and Mgmt X442.6, Medical Product Quality Systems; or equivalent experience.