Medical Device – QSR Compliant Product Development Process: One and half day In-person Seminar

By: Russell Pizzuto, President- Consultant at PPRE Consulting LLC.
Coming soon.. Please contact customer care for new schedule
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)
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
Day Two (8:30 AM - 1:30 PM)
  • 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
    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.


    Grand Hyatt San Francisco
    345 Stockton Street,
    San Francisco, California, USA, 94108

    January 23-24, 2014
    Special Offer for the attendees of this seminar:
    Rooms available at 15% discount and with free internet.
    Use the code "CR88975" at the time of booking to avail of this offer
    Please note: Hotel rooms are limited and based on availability

    How to Reach

    General Driving Directions:

    From San Francisco International Airport: 14 miles
    • Take 101 North toward the San Francisco and Bay Bridge.(Cambridge)
    • Exit 280 North toward "Port of SF/280 North". Stay in left lane and 280 becomes King Street.
    • At 2nd light, turn left onto 3rd St and go 8 blocks to Market St.
    • Cross over Market St. (which becomes Kearny St.) and continue 2 blocks.
    • Turn left on Sutter St. Go 2 blocks to Stockton and the hotel is located on the left corner.

    From Oakland Airport: 20 miles
    • Take 880 North toward San Francisco and cross over on the Bay Bridge.
    • Take the Fremont St. Exit (on right) & proceed 1/2-block on Fremont St.
    • Turn left onto Howard St & Turn right onto 3rd St.
    • Cross Market St. (Street changes to Kearny).
    • Take Kearny 2 blocks to Sutter St. and turn left.
    • Take Sutter St. to Stockton St. and turn left.

    From San Jose International Airport: 46 miles
    • Take 101 North toward San Francisco for approximately 43 miles
    • Take I-80 East toward Bay Bridge/Oakland.
    • Exit at Fourth Street toward Embarcadero.
    • Make a slight left onto Bryant Street.
    • Then a left onto Third Street & Third Street will become Kearny Street.
    • Take Kearny 2 blocks to Sutter St. and turn left.
    • Take Sutter St. to Stockton St. and turn left to reach the Hotel.

    Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

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