In this “hands on” course participants will design a product utilizing regulations for design control and application of risk management. Participants will learn how to perform risk management, plan design activities, determine design inputs and outputs, verification, validation, how to handle design changes, and the contents and maintenance of a Design History File.
By the end of the course, participants will be able to:
- Describe FDA Regulations for Design Controls
- Perform product risk management for design control
- Perform design planning
- Identify design input and outputs
- Perform a design review
- Identify design verification and validation
- Perform design transfer
- Perform design changes
- Maintain a Design History File
Who Should Attend:
Although Design Control is a regulation for medical devices, those who are involved with any part of product development in a regulated environment are encourage to attend. This can include purchasing, quality, regulatory, manufacturing, product development, as well as other functions.
No pre-requisites required. Overview of FDA Regulations and Quality Systems Overview (or relevant experience) are highly recommended.
Cost: One-day class
Location: Location and driving directions will be emailed separately upon registration.