DAY ONE

Introduction to Design Control

• Importance of effective design philosophy for performance and safety
• Use of international standards
• Effective use of risk management techniques
• Discussion of risk management procedure

Quality System Aspects

• Purpose of quality system
• Quality system strategy for compliance with Design Control
• Typical quality system procedures, forms, and records relating to Design Control

Implementing Top Level Design Control Procedure

• Specification based approach to design control
• Examples of specification models
• Project planning
• Discussion of various document types  specifications, design documents, plans, test documentation, drawings, design documents, traceability matrices, design review minutes, and risk analyses

                                                          DAY TWO

Safety and Risk Management

• Importance of effective design philosophy for performance and safety
• Use of international standards
• Effective use of risk management techniques
• Discussion of risk management procedure

Validation and Verification (V&V)

• Definitions
• Strategies considerations for validation
• Strategies considerations for verification
• Design Reviews
• Statistical techniques
• Procedural discussion for V&V, design reviews, statistical methods
• Requirements for managing prototypes, including units scheduled for field

Software Considerations

• Discussion of FDA software guidelines
• Special considerations for software
• Software improvement models
• Discussion of software development procedure

Manufacturing Transfer

• Integrating manufacturing considerations into design
• Documentation for Design History Files vs. Device Master Record (manufacturing documents and procedures), techniques to minimize duplication
• Product vs. process considerations
• Discussion of process validation
• Discussion of manufacturing transfer procedure

Integrating General Quality Procedures in Design Control

• Documentation control procedures
• Configuration management/change control procedures
• Training procedures
• Auditing procedures
• Equipment calibration