Units
2.0 QUARTER UNITS
Course Description
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).
Topics
- Differences between verification and validation.
- Validation planning and Master Validation Plan
- How to Conduct Process Validation
- Process Validation Aftermath
Prerequisites / Skills Needed
Working knowledge of:
- The FDA quality management system requirements and ISO 13485:2016
Additional Information
This is an intermediate/advanced level class geared towards students and medical device professionals who work in quality engineering, product design and development, manufacturing engineering, quality assurance, quality compliance and regulatory affairs.
AI* - This course encourages the use of AI tools for editing, translation, idea generation, visualization, and tutoring, while teaching students how to properly cite any AI-generated content.
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