Our Approach
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