Course "Medical Device - QSR Compliant Product Development Process" has been pre-approved by RAPS as eligible for up to 10 credits towards a participant's RAC recertification upon full completion.

Course Description:

Integrating the requirements of 21 CFR 820 into a product development process is challenging. Done poorly, it drags down the design process and puts you at risk. Done well, it delivers quality products, resource efficiencies and compliance that are easily demonstrated to the FDA.

You can’t afford to be in a position where either design controls or the product development process are weak. Design controls are essential to safety and effectiveness. The FDA reports ineffective design controls are the root cause of as many as 31% of recalls. Ineffective product development processes are slow, costly and often miss significant business objectives.

This seminar on quality system regulations for medical devices will show you how to build a best practice stage gate product development process that not just incorporates 21 CFR 820 design controls but keeps you ahead of the competition and easily shows compliance during an audit. The process showcased in this course will also fulfill QSR requirements, produce the objective evidence necessary to prove compliance, manage resources and deliver quality products.

Learning Objectives:

The seminar will focus on understanding:

  • The key elements of 21 CFR 820 design controls
  • Best practice stage gate product development
  • How 21 CFR 820 design controls can be integrated into a stage gate product development process
  • How to link to intended use, user needs, risk management and manufacturing processes
  • How to manage both new product development and design changes
  • How to manage marketing, costs and schedule requirements in parallel with the regulatory processes
  • How to systematically create the required objective evidence and how to easily produce it during an audit

Who will Benefit:

  • Project managers
  • Quality managers and staff
  • R & D, product development and sustaining engineering, managers and staff
  • Design transfer managers and staff
  • Regulatory and compliance managers and staff
  • Compliance and product development consultants
  • Anyone with product development, risk management, regulator or quality assurance responsibilities

Course Outline:

Day One (8:30 AM - 4:30 PM) Day Two (8:30 AM - 1:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Welcome and Introductions

  1. Product Development Processes
    • What is a stage gate process
    • Stage Gate Phases
    • Sub-processes
      • FDA Design Controls
      • FDA Change Controls
      • Business Process
      • Design & Development
  2. FDA Design Controls Overview (21 CFR 820)
  3. Project Portfolio Management
    • Product Line Roadmap
    • Technology Roadmap, R&D
    • Project Gating
  4. Project Inputs
    • Business Case
    • Marketing Specification
    • Quality Documents
    • Regulatory, Safety and Industry Standards
  5. Design Archives
    • Design History File
    • Traceability Matrix

  • Welcome (15 Minutes)
    1. QSR Compliant Stage Gate Product Development
      • Stage Gate Process Phases
        • Concept and Feasibility
        • Planning & Design Inputs
        • Prototype
          • Detailed Design & Design Outputs
          • Design Verification
        • Pre-Production and Validation
      • For Each Project Phase
        • Content with Examples
        • Best Practices
        • QSR Design Controls Deliverables
        • Business Deliverables

    Meet Your Instructor

    Russell Pizzuto
    President- Consultant at PPRE Consulting LLC

    Russell Pizzuto has 40 year of experience in engineering and management with 11 years in medical device design, manufacturing and regulatory compliance. As a Design Engineering, Project Engineer and Director of New Product Development Mr. Pizzuto has developed hundreds of new consumer and industrial products for fortune 500 companies. As Global Director of Engineering for a major medical products manufacturer with teams in USA, Europe, China and Mexico he delivered Class I and Class II medical device projects.

    For the last two years he has served as President of PPRE Consulting, specializing in Product, Project and Regulatory Engineering. He holds a Medical Device certificate from the Regulatory Affairs Professionals Society (RAPS), has work on the FDA’s Hospital Bed Safety Work Group and served as an expert witness in Hospital Bed Safety litigation. He has most recently focused on helping clients under FDA legal action, to bring their Design Control and Risk Management Systems into compliance.

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