21 CFR 820 Best Practice, Requirements Traceability From Source Documents Through Design Validation

Duration: 90 Minutes
This seminar will show you how to effectively integrate requirements traceability into your product development process. This systematic process links all User Needs, Intended Uses, regulatory requirements and functional requirements from source documents through Design Inputs, Design Output, Design Verification and Design Validation.
21 CFR 820 Best Practice
Instructor: Russell Pizzuto
Product ID: 500346

This best practice will help ensure that your development programs and design changes have met all project design requirements related to safety and effectiveness, and help demonstrates 21 CFR 820 Design Controls compliance.

It is challenging to ensure that all design requirements related to product safety and effectiveness are met. You can’t afford to be in a position where your design control system is weak and does not effectively show how each design, regulatory and safety requirement has been satisfied. This is essential for both developing/maintaining safe and effective products, and to demonstrating QSR 21CFR 820 compliance to the FDA.

Objectives of the Presentation:
The seminar will focus on understanding:
  • How to define source document and design requirements
  • How to link to source documents: intended use, user needs, risk analysis, product spec, industry standards…
  • How to create a Traceability Matrix that traces:
    • Source document to Design Input (including Essential Design Inputs)
    • Design Inputs to Design Outputs to Design Verification and to Design Validation
  • Integration into a product development process and the DHF
  • How to use traceability in new product development and design changes
  • How this process systematically creates objective evidence and how to easily produce it during an audit
Who can Benefit:
  • Project Managers
  • Quality Managers and Staff
  • R&D, Product Development and Sustaining Engineering, 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
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in PDF format will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in PDF format will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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  $500.00 Training CD
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Minimum 10 attendees
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Russell Pizzuto has 40 year of experience in engineering and management with 12 years in medical device design, manufacturing and regulatory compliance. As a Design Engineering, Project Engineer and Director of New Product Development he 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. Mr. Pizzuto 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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