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


Contact Us