Integrating ISO 14971 Risk Analysis Into the Product Development Process

Duration: 90 Minutes
This seminar will present a best practice for integrating risk analysis into a Quality System. That integrated risk analysis process creates a closed loop system that identifies risks, defines downstream risk based requirements and analyzes feedback from downstream process to adjust hazards, risk levels and requirements. The integrated processes spans new product development, design change, production, and post market surveillance for the lifecycle of the device. Objective evidence produced by the integrated processes can be used to verify risk analysis compliance to 21 CFR 820 and ISO 14971 during an audit.
ISO 14971 Integration
Instructor: Russell Pizzuto
Product ID: 500358

Effective risk analysis systems help deliver safe and effective medical devices. The best risk management processes help anticipate risks. For these reasons the FDA has increased their emphasis on risk analysis. The regulations require ongoing risk management that spans the medical device lifecycle. To satisfy that requirement, risk analysis must be integrated into new product development, design change, PFMEA, CAPA and post market surveillance systems. Integration creates a closed loop system where information is passed back and forth.

This seminar will help you implement a risk analysis system that is integrated into downstream processes for the life cycle of the device. This is essential to delivering safe and effective medical devices and to demonstrate 21CFR 820 / ISO 14971 compliance.

Why Should you Attend:
  • Learn how to establish a efficient and effective risk analysis system
  • Fewer audit findings, adverse events and recalls
  • A 21 CFR 820 / ISO 14971 compliant Risk Analysis
  • This process provides:
    • Objective evidence for audits
    • Risk based verification and validation requirements
    • Hazard inputs to New Product Development/Design Inputs
    • Risk evaluation of design changes and CAPA's
    • Baselinefor post market data evaluation
    • Closed loop system that spans the lifecycle
Objectives of the Presentation:
The seminar will present:
  • Several risk analysis formats
  • How to identify "Hazards"
  • How to calculate "Probability of Occurrence"
  • How to determine level of "Harm"
  • How to define the level of "Risk"
  • Down Stream Action Requirements (risk based)
    • Highest- Validation required
    • Moderate - Verification required
    • Design Input(s) created for some
    • Risk vs. Benefits Analysis
  • How to connect hazards to Design Inputs for action & traceability
  • How to systematically produce objective evidence
  • How to evaluate and document risks associated withdesign changes, complaints, adverse events, CAPA and mfg deviation (PFMEA)
Who can Benefit:
  • Quality managers and staff
  • Regulatory and Compliance managers and staff
  • Product Development and Sustaining Engineering, managers and staff
  • Project Managers
  • Compliance and Product Development Consultants
  • Anyone with Product Development, Risk Management, Regulator or Quality Assurance responsibilities
Recorded Session for one participant
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Live Session - How it works
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  • 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
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  • 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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