The Center for Professional Innovation & Education (CfPIE), Malvern, PA
Apr. 12 & 13, 2007
Who Should Attend Because of its comprehensive overview, this course will be most valuable to medical device industry engineers, engineering managers, regulatory affairs professionals, scientists, and quality engineers, whether in product development, manufacturing, quality assurance, or regulatory affairs, who are new to the industry or to their current position and do not have an in-depth knowledge of the Design Control and its workings. The program can also be customized for more experienced personnel, including middle and upper management, to update and broaden their knowledge of FDA’s Design Control requirements. Learning Objectives Upon completion of this course, you will have gained an understanding of how to effectively meet the requirements of design control for medical devices. An emphasis will be placed on effective design strategy – strategy is very important to avoid spending unnecessary time and money on an ineffective design control process. The first day will cover the general context for design control, required procedures, and the discussion of the general design control procedure. The second day will discuss additional regulatory topics and procedures. Manufacturing transfer and general quality system topics will be covered as they relate to the design process. Included with this course are extensive Course Notes that are frequently used by attendees as reference material once the course is completed. Course Description This continually updated course covers current FDA regulatory compliance with respect to developing medical devices. A focus will be placed on basic regulation and the FDA's supplemental guidelines. Among the topics to be discussed are: Context of design control within the overall quality system and regulation, design control procedures, forms, records, safety/risk management strategies, documentation strategies, manufacturing transfer strategies, and strategies for integrating general quality system procedures into design control. ________________________________________ COURSE AGENDA FIRST DAY
Introduction to Design Control • Background of FDA regulation (law)
• Discussion of FDA guidelines (recommendations)
• Class I, II, and III device discussion
• FDA vs. ISO 9001 aspects 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. SECOND DAY 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
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