Design Controls Concepts and Implementation – Virtual April 21-22, 2025

Course Outline

FDA Requirement

• FDA’s major areas of concern
• CDRH’s cradle-to-grave vision: The Total Product Life Cycle
• Design control as part of the Quality System Regulation (QSR)
• FDA’s definition of key design terminology

Design and Development Planning – 21 CFR 820.30

• Implementing top-level design control procedures
• Best practices in design planning
• Design Review – 21 CFR 820.30 (e)
• Types of review
• Proven design review methods

Design Input – 21 CFR 820.30 (c)/ Design Output– 21 CFR 820.30 (d)

• Understanding inputs vs. outputs
• Typical input documents
• Using FDA recognized standards and guidance
• Important of Human Factor considerations
• Other final output documents
• Conducting design output review

Design Verification– 21 CFR 820.30 (f) / Design Validation– 21 CFR 820.30 (g)

• Verification documents
• Understanding difference between verification vs. validation
• Elements of a test protocol
• What FDA looks for in test reports
• What if the design fails V&V?
• How FDA defines validation
• Key validation documents and methods
• Conducting design validation review

Design Change – 21 CFR 820.30 (i) / Design Transfer to Manufacturing– 21 CFR 820.30 (h) / Design History File (DHFs) – 21 CFR 820.30 (j)

• Developing a change control policy
• Identifying all areas impacted by change
• Conducting re-verification and re-validation
• Integrating manufacturing considerations into design
• Key design transfer documents
• FDA requirements for design history
• Relationship between the DHF and the Device Master Record (DMR)
• Creating a traceable DHF index