Product Details
Medical Device Process Validation
Process valiation can be a daunting propect. What should you do? When should you do it? What records should you keep?
With no clear guidance from the FDA, finding the answers can be difficult.
Join industry expert Dan O’Leary, President of Ombu Enterprises, LLC, as he discusses the fundamental requirements of medical device process validation and uses warning letters to illustrate best practices.
After attending this 90-minute training session you will:
- Understand the three phases of process validation in QSR
- Understand the role of IQ, OQ, and PQ in the first phase
- Learn the issues of parameter control, data collection, and data analysis applied to production runs
- Review the QSIT approach and how FDA Investigators apply it
- Analyze warning letters and apply lessons learned
- Realize the differences introduced in ISO 13485:2016
Order today and discover how to set up a compliant process validation system.