Our Approach

Design Controls & Risk Management: An Integrated Product Development Approach


Day One

 1) Introduction

  • Instructor and Class Introductions
  • Course Objectives & Expectations
  • Review Participant Objectives


2) Overview of Design Controls 

  • What is Design Control? (Concepts Defined)
  • Why is Design Control important?
  • FDA’s Cradle to Grave Vision of the Total Product Life Cycle
  • The “Unwritten Laws” of Design Control (Planning, Documentation, Risk Based Approach, Interactions)


3) Phase 0 (Research)

  • Timing of Design Control Elements During Product Development
  • When Does Design Controls Start? When Does It End?
  • Concept & Feasibility
  • Development phases overview (phase 0-V)


4) Phase I (Requirements & Planning)

  •  Design and Development Planning
    • Why does FDA require planning?
    • Developing Practical Design and Development Plans
    • Topics Addressed in DDP
  •  User Needs & Marketing Inputs
    • What Are User Needs?
    • Characteristics of Effective User Needs
    • Identifying User Needs
    • User Needs vs. Marketing Inputs
    • Review User Needs
    • Workshop Exercise: Developing User Needs

(Group Break Out)

  • Design Input Development
    • What Are Design Inputs?
    • Characteristics of Design Inputs
    • Purpose of Design Inputs
    • Design Inputs vs. User Needs
    • Intended Use
    • The Process of Developing Effective Design Inputs
    • Design Inputs & Human Factors 
    • Review Design Inputs
    • Workshop Exercise: Develop Design Inputs (Group Break Out)

 Risk Management Planning

    • How to perform risk planning
    • Examples


5) Phase II

  • Preliminary Design
  • Preliminary Hazard Analysis
    • What is a Preliminary Hazard Analysis and why is it important?
    • Elements of a Preliminary Hazard Analysis
    • Preliminary Hazard Analysis Exercise
  • Detail Design and Development / Testing
  • Risk Assessment
    • Hazard Analysis
    • Risk Analysis
    • Risk Evaluation
    • Workshop Exercise: Performing a Risk Assessment

(Group Break Out)

  • Risk Mitigation and Control
    • Identifying Risk Controls and Implementation
    • Workshop Exercise: Implementing Risk Controls

(Group Break Out)

  • Design Reviews
    • Purpose of Design Reviews
    • Reviewer Roles
    • Documenting Design Reviews
    • Formal vs. Informal Reviews
    • Types of Design Reviews
    • Characteristics of Effective Design Reviews
    • Practical Implementation and Best Practices

Day Two

  • Design Output
    • What are Design Outputs? What are Essential Design Outputs?
    • Effectively Documenting Design Outputs
    • What is the Device Master Record?
    • Exercise: Identifying Design Outputs


  • Design Verification
    • Purpose of Design Verification
    • Types of Verification
    • Verification Planning
    • Documenting Verification: Protocol and Report Designs
    • Practical Implementation and Best Practices
    • Workshop Exercise: Effectively Plan and Execute Verification

(Group Break Out)

 Design Transfer Planning & Initial Design Transfer Activities (Phase I&II)

    • Purpose of Design Transfer
    • Three Key Components of Effective Design Transfer Procedures
    • Documenting Design Transfer Activities and Deliverables
    • Design Transfer: It's a Process, Not an Event!
    • The Design Transfer Process: Planning, Execution, Qualification
    • The Design Transfer Team and Design Transfer Reviews
    • Practical Implementation and Best Practices

   6) Phase III (Design Transfer)

  • Final Design Transfer / Final Execution (Phase 3)


  7) Phase IV

  • Design Validation
    • Purpose of Design Validation
    • What Is Design Validation?
    • Validation vs. Verification (What's the difference?)
    • Types of Validation
    • Is Process Validation a Part of Design Validation?
    • Validation Planning & Human Factors: A Risk Based Approach
    • Documenting Validations: Protocol and Report Designs
    • Practical Implementation and Best Practices
    • Workshop Exercise: Design Validation (Group Break Out)

 Final Risk Assessment Verification: Effectiveness

  • Risk Management Report
    • What is included in a risk management report?
  • Risk Management: Production and Post-Production Information
    • Implementing a production and post-post production feedback process

  8) Phase V

  • Regulatory Submission & Approval
  • Commercialization & Product Launch

 9)   Design History File

  • Purpose of the Design History File
  • Contents of a Design History File and Record
  • DHF vs. DMR vs. DHR
  • DHF vs. Technical File vs. 510k

 10) Design Change

  • Purpose of Design Change
  • Document Control vs. Change Control
  • When Should Design Change Begin?
  • Design Change Process (Development vs. Production)
  • Elements of Effective Design Change
  • Practical Implementation, Best Practices, and Examples

 11) Question and Answer Session / Course Evaluation


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