ComplianceOnline

Life Cycle Risk Management for 21 CFR 820 and ISO 13485

Instructor: Russell Pizzuto
Product ID: 704964
Training Level: Intermediate
  • Duration: 90 Min
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Read Frequently Asked Questions

This webinar will present a Lifecycle Risk Management System that meets FDA and ISO requirements. That risk management system (based on ISO 14971) creates a closed loop system that identifies risks, and uses field use feedback to adjust risks and to improve designs and processes. The objective evidence produced by a Lifecycle Risk Management Systems can be used to demonstrate risk management compliance to 21 CFR 820 and ISO 13485.

Why Should You Attend:

Effective risk management systems help deliver safe and effective medical devices. The best risk management processes help anticipate risks. For these reasons the FDA and ISO have increased their emphasis on risk management.

21 CFR 820 and ISO 13485 require ongoing risk management (based on ISO 14971) that spans the medical device lifecycle. To satisfy those requirements, risk management must be integrated into new product development, design change, manufacturing, CAPA and post market surveillance systems. Integration creates a closed loop system where post market data is fed back into product development and manufacturing.

This webinar will help you implement or improve a Lifecycle Risk Management System and to demonstrate 21 CFR 820 / ISO 13485 risk management compliance.

Areas Covered in the Webinar:

  • What is Lifecycle Risk Management
  • FDA 21 CFR 820 Risk Management Requirements
  • ISO 13485 Risk Management Requirements
  • Fundamental of ISO 14971 Risk Assessment
    • How to identify “Hazards”
    • How to calculate “Probability of Occurrence”
    • How to determine level of “Harm”
    • How to define the level of “Risk”
    • Risk Bases Down Stream Action Requirements
    • Risk vs. Benefits Analysis
  • How to connect hazards / risks to Design and Manufacturing Processes
  • How to connect to Post Market Activities
  • How to create the Reports and Objective Evidence necessary to satisfy 21 CFR 820 and ISO 13485 Risk Management Requirements

Who Will 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
Instructor Profile:
Russell Pizzuto

Russell Pizzuto
President, PPRE Consulting LLC

Russell Pizzuto has 40 year of engineering and management experience with 14 years in medical device design, manufacturing and regulatory compliance. Early in Mr. Pizzuto career he developed hundreds of new consumer and industrial products for fortune 500 companies. As Global Director of Engineering for a major medical device manufacturer with teams in USA, Europe, China and Mexico he delivered Class I and Class II medical device projects.

For the last 5 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 serves 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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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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