Design Control – Online

Training Dates: August 26 and 27, 8 a.m. – 12 p.m.

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

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