Has your organization documented the flow of the design process so it is clear to an FDA inspector where your research ends and design development begins? FDA has identified design control as a key area in its QSIT top-down inspectional approach of compliance. According to the FDA, "Manufacturers must incorporate a set of checks and balances in their design processes to assure a safe, effective finished product." Learn how to control the design process to assure that your organization's devices meet user needs, intended uses, and specified requirements. In-depth discussions and workshops cover design and development planning, sound design inputs and corresponding design outputs, why and how to verify that design outputs meet design inputs, design validation, control of design changes, design results, transferring the design to product manufacturing, and the design history file. Class exercises explore the interface of design control with other important elements of a robust design process such as risk analysis and corrective and preventive action processes.