Build validation protocols and learn how to meet FDA and global regulatory standards.
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).
Working knowledge of:
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.
This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.
No meeting on February 18, 2026. To see all meeting dates, click "Full Schedule" below.
You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.
Required Text:
Quality Management Systems - Process Validation Guidance, 2nd ed., SG3,
Code of Federal Regulations Title 21
