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.

Objectives

• Understand the role of the control of design and development in the regulated medical device industry.
• Review and compare design control in the QSR and ISO 13485.
• Understand the "process model" approach to design control.
• Identify the individual elements of the design control process.
• Understand the phases of the product life cycle and its relation to design control.
• Learn how to structure design control using good project management techniques.
• Guide your organization in building a successful design control team.
• Develop the proper interface of design control with risk management and CAPA processes.
• Recognize the proper use of postproduction information in design control.
• Learn the expectations of the FDA and its QSIT approach to inspection in relation to design control.

Topics

• FDA, ISO, and design control
• Key terms and definitions
• Principles of the "process model"
• Overview of the design control process model
• Examination of the elements of design control process
• The design control team
• Product life cycle and design control
• Design control, risk management, and CAPA
• Building the compliant design history file (DHF)
• QSIT and design control

Who Should Attend

Anyone managing, developing, or engaging in the design of medical devices, including direct engineering functions, QA/QC, production management, regulatory, and any others that have a role in building a robust regulatory compliant environment.

CEUs: 1.5
Number of Days: 2