Understanding Design Controls 2017

Topics

• A drill down through each step of the design control process
• An overview of the design control guidance for design controls
• The Design Control Plan – its contents, functions, and uses
• An explanation and differentiation between verification and validation
• An overview of Adaptive Design and the recently produced FDA guidance explaining it
• The design control life cycle process

Who should Attend

• Regulatory
• Quality
• R & D
• Compliance
• Manufacturing and Engineering
• Design and Development
• Anyone involved in the Manufacture of Medical Devices that has had some exposure to the subject area and regulated environments