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Process Validation for Medical Device Development

Course Description

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.

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  • Details
  • $725
  • Reg#: 00117
  • ID/Units: BME X407  (3.00)
    ( Section 1 )
  • Quarter: SPRING 2021