Design Controls (Basic/Intermediate) Course Agenda / 2 Days

Day One

1) Introduction

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

2) Overview of Design

  • What is Design Control? (Concepts Defined)
  • The History of Design Control
  • Why is Design Control important?
  • FDA’s Cradle to Grave Vision of the Total Product Life Cycle
  • Timing of Design Control Elements During Product Development
  • The “Unwritten Laws” of Design Control (Planning, Documentation, Risk Based Approach, Interactions)
  • Relationship of Design Control Elements (The Design Control Relationship Web)
  • Medical Device Class (I,II,III)
  • Quiz

3) FDA Regulation, Guidance and Other Industry Standards and Resources

  • 21 CFR 820.30 Regulation
  • Design Control Guidance
  • Quality System Preamble
  • ISO 13485 (A comparison with 21 CFR 820.30)

 4) Design and Development Planning

  • Why does FDA require planning?
  • Design and Development Planning Regulation Review and Interpretation
  • Developing Practical Design and Development Plans
  • Topics Addressed in DDP
  • Example
  • Quiz

5) Design Input

  • Conceptual Example
  • Design Input Regulation Review and Interpretation
  • Purpose of Design Inputs
  • Concept Documents vs. Design Inputs
  • Quiz

Lunch

  • Types of Design Input (design requirements, user needs, etc)
  • Examples
  • The Process of Developing Effective Design Inputs (design req. and user needs)
  • Design Inputs & Human Factors
  • Quiz
  • Workshop Exercise: Developing Effective Design Inputs (Group Break Out)

6) Design Output

  • Conceptual Example
  • Regulation Interpretation
  • What are Design Outputs? What are Essential Design Outputs?
  • Examples
  • Effectively Documenting Design Outputs
  • What is the Device Master Record?
  • Quiz
  • Exercise

8) Question and Answer Session

Day Two 

9) Design Review

  • Design Review Regulation and Interpretation
  • Purpose of Design Reviews
  • Reviewer Roles
  • Documenting Design Reviews
  • Formal vs. Informal Reviews
  • Types of Design Reviews
  • Examples
  • Characteristics of Effective Design Reviews
  • Practical Implementation and Best Practices
  • Quiz
  • Exercise

10) Design Verification

  • Conceptual Example
  • Design Verification Regulation Review and Interpretation
  • Purpose of Design Verification
  • Types of Verification
  • Verification Planning
  • Documenting Verification: Protocol and Report Designs
  • Examples
  • Practical Implementation and Best Practices
  • Quiz
  • Workshop Exercise: Effectively Plan and Execute Verification (Group Break Out)

11) Design Validation

  • Conceptual Example
  • Design Validation Regulation Review and Interpretation
  • Purpose of Design Validation
  • Validation vs. Verification (What's the difference?)
  • Types of Validation
  • Examples

Lunch

  • Risk Analysis (ISO 14971 Risk Management)
  • Software 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
  • Quiz
  • Workshop Exercise: Effectively Plan and Execute Validations (Group Break Out)

12) Design Transfer 

  • Design Transfer Regulation Review and Interpretation
  • 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
  • Example / Template
  • The Design Transfer Team and Design Transfer Reviews
  • Practical Implementation and Best Practices
  • Quiz
  • Exercise   

13) Design Change

  • Design Change Regulation Review and Interpretation
  • 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
  • Quiz
  • Example

14) Design History File (DHF)

  • Design History File Regulation Review and Interpretation
  • Purpose of the Design History File
  • Contents of a Design History File and Record
  • Examples
  • DHF vs. DMR vs. DHR
  • Quiz

15) Question and Answer Session