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Course Agenda
Day One (8:30AM - 4:30PM)

8:00 – 9:00 AM: Registration

Welcome and Introductions

I. FDA - Barriers to Medical Device Quality
  • Gaps in Quality System
  • Seven Opportunities
  • Span the Lifecycle
  • Predictive Systems

II. LifeCycle Process
  • Business, Design & Manufacturing Processes 
  • High Level Process Description
                 - Device Lifecycle, Design, Risk Management
  • Process Integration Model

III. Risk Management
  • Objectives, Plan, Design, Verify, Validate, Monitor
  • Risk Management Lifecycle Model
  • ISO 14971
             - Process Stages
             - Risk Management Plan
             - What is Risk
                    - Design, Mfg., Clinical, Human Factor​
             - Hazard, Probability, Harm
             - Risk Matrix, Risk Benefit Analysis
             - Closing the Loop
                  - Post Market Surveillance, CAPA, Corrections & Removals
                  - Management Review​
  • EU – Annex A Requirements
Day Two (8:30 AM - 4:00PM)

Welcome (15 Minutes)

IV. FDA Design Controls
  • 21 CFR 820 Design Controls Sections
  • Design Controls Requirements 
                 - Planning
                 - Design Input
                 - Design Output
                 - Design Review
                 - Design Verification
                 - Design Validation
                 - Design Transfer
                 - Design ChangeDesign History File

V. Integrated Risk Management and Design Control
  • Stage Gates – Linkage -- Traceability
  • Step Through Integrated Processes Linking Items
                  - Initial Risk Assessment, Source Requirements
                  - Risk Management and Design Plan
                  - Initiate Risk and Design Traceability Matrix
                  - Create Design Input Linked to Sources
                  - Proceed through Output, Verification & Validation
                  - Design Transfer Tracing Critical Quality Attributes
                  - Manufacturing Validation and Control
                  - Feedback – Process Controls, Post Market, CAPA
                  - Management Review