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Medical Device Process Validation | MEDD.X411

Validation is a critical aspect of medical device development and manufacturing and insufficient or noncompliant validation is a common reason for warning letters. Through lectures, assignments, in-class games, you will learn about industry best practices in a hands-on manner on how to set up and maintain a validated process. Utilizing an example surgical device, you will gain a thorough understanding of when to validate a process, how to develop and conduct IQ/OQ/PQ, qualify methods through Gage R&R, and extend concepts to sterilization and packaging validation. You will also be provided templates for validation plans, validation protocols and reports that are compliant with US FDA regulations as well as harmonized regulatory requirements from the IMDRF (International Medical Device Regulators Forum).

Learning Outcomes:
At the end of the course, students should be able to

  • Identify FDA and harmonized IMDRF requirements for validation of medical device manufacturing processes
  • Explain the criticality of validation and the consequences of insufficient validation on product quality and compliance
  • Develop a validation protocol based on risk-based analysis of the production process and conduct a validation study
  • Understand process monitoring to maintain a validated state, and developing impact analyses for design and process changes
  • Analyze measurement systems through Gage R&R studies
  • Apply principles to other validation of processes like cleaning, sterilization and packaging based on identifying key international standards

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