This two-day course will introduce current FDA QSR/cGMP
compliance requirement (21 CFR Part 820.30) with respect to developing
medical devices as well as the latest industry practices for developing
medical device design projects in accordance with the specified
requirements.
In addition to FDA抯 expectations and perspectives,
examples of design control procedures, forms, records, tools, and
practices will be presented and discussed during the course, which
provides practical resources for future reference. Situation analyses
and case studies, specifically designed for different device
classifications and company sizes, are used throughout the program to
help attendees analyze potential areas of noncompliance, identify
improvements, and evaluate the various methods of developing and
managing a design control program.
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Basic Review of Compliance Requirements
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Effective design philosophy for performance and safety
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Elements in design control system
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Standard and minimum provisions
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Strategy for Medical Device Design Projects
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Quality system strategy for compliance with design control
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Typical structure of a design development project
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Planning a Design Project
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Specification based approach to design control
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Examples of specification models
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Project planning
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Determination of Design Inputs and Outputs
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Translation of customer requirements to design inputs
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Considerations in design process
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Design outputs
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Design Verification and Validation
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Requirements and strategic considerations
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Tools and techniques
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Procedural discussion for V&V
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How to manage prototypes
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Technology (Design) Transfer
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Integrating manufacturing considerations into design
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Considerations in transfer
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Techniques to minimize duplication
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Safety and Risk Management
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Risk management procedure
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Effective use of risk management techniques
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Software Considerations
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FDA software guidances
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Special considerations for software
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Software improvement models
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Software development and validation procedures
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Design Reviews and Documentation
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Design review in the design process
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Design history files
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Change Control System
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Configuration management
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Control techniques
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FDA Inspection Focus
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How does FDA inspect design control system
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Organization for FDA presentation
