Design Control and Transfer for Medical Devices
Meeting FDA's 21 CFR 820.30 Rules for Quality Design and Manufacturing

(2 day course)

Course Content:
 

• Why Does FDA Require Design Controls?

  • 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

• FDA Guidance for Design Control

  • Defining a “substantially equivalent” production unit

  • Understanding difference between a deviation vs. nonconformance

  • Understanding difference between project design vs. product design

  • How international standards relate to FDA’s expectations
     

• Design and Development Planning – 21 CFR 820.30 (b)

  • Implementing top-level design control procedures

  • Elements of the General Development (GDP)

  • 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)

  • Understanding inputs vs. outputs

  • Typical input documents

  • Using FDA recognized standards and guidance

  • Important of Human Factor considerations

  • Good and bad examples of requirements
     

• Design Output– 21 CFR 820.30 (d)

  • Process controls outputs

  • Other final output documents

  • Conducting design output review
     

• Design Verification– 21 CFR 820.30 (f)

  • 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?
     

• Design Validation– 21 CFR 820.30 (g)

  • How FDA defines validation

  • Key validation documents and methods

  • Conducting design validation review
     

• Design Change – 21 CFR 820.30 (i)

  • Developing a change control policy

  • Role of planned, temporary changes

  • Identifying all areas impacted by change

  • Conducting re-verification and re-validation
     

• Design Transfer to Manufacturing– 21 CFR 820.30 (h)

  • Integrating manufacturing considerations into design

  • Key design transfer documents

  • Developing a manufacturing/transfer plan

  • Proven design transfer methods
     

• Lessons learned in Design Transfer

  • Documentation reminders

  • Impacts on tooling and components

  • Conducting design transfer review

  • Importance of process control review
     

• Design History File (DHFs) – 21 CFR 820.30 (j)

  • FDA requirements for design history

  • Responsibilities of team leaders

  • Relationship between the DHF and the Device Master Record (DMR)

  • Creating a traceable DHF index

  • Practical suggestions maintaining compliance

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