Building Closed Memorial Day Weekend
The Silicon Valley Campus is closed Saturday, May 27 through Monday, May 29, 2023, in honor of Memorial Day. We will reopen for classes on Tuesday.
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 OutcomesAt the conclusion of the course, you 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
- Differences between verification and validation.
- Validation planning and Master Validation Plan
- How to Conduct Process Validation
- Process Validation Aftermath
Working knowledge of:
- Google Workspace or Microsoft Office to submit assignments
- Canvas navigation links, modules, and using the inbox to communicate with the instructor
- The FDA quality management system requirements and ISO 13485:2016
Additional InformationPlease review section notes to view the full schedule.
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.
Next Section Starts In:
June 14, 2023, 6 p.m.
Have a question about this course?
- Save Your Seat
Help us confirm course scheduling. Enroll at least seven days before your course starts.
- Accessing Canvas
Learn more about gaining access to your course on Canvas in our FAQ section.
Accessibility and Accommodation
For accessibility questions or to request an accommodation, please visit Access for Students with Disabilities or email the Extension registrar.
Finance Your Education
Here are ways to pay for your education.
This course is related to the following programs:
Sections Open for Enrollment:
|Date:||Start Time:||End Time:||Meeting Type:||Location:|
|Wed, 06-14-2023||6:00 p.m.||9:00 p.m.||Live-Online||REMOTE|
|Wed, 06-21-2023||6:00 p.m.||9:00 p.m.||Live-Online||REMOTE|
|Wed, 07-05-2023||6:00 p.m.||9:00 p.m.||Live-Online||REMOTE|
|Wed, 07-12-2023||6:00 p.m.||9:00 p.m.||Live-Online||REMOTE|
|Wed, 07-19-2023||6:00 p.m.||9:00 p.m.||Live-Online||REMOTE|
|Wed, 07-26-2023||6:00 p.m.||9:00 p.m.||Live-Online||REMOTE|