Integrating ISO 14971 Risk Analysis into the Product Development Process
Instructor:
Russell Pizzuto
Product ID: 704926
Training Level: Intermediate
- Duration: 90 Min
Why Should You Attend:
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.
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 post market data is fed back into the product development and manufacturing systems.
This webinar 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 21 CFR 820 / ISO 14971 compliance.
Areas Covered in the Webinar:
- 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”
- Risk Bases Down Stream Action Requirements
- Highest - Verification and Validation required
- Moderate - Verification required
- Low – Process Documentation Only
- 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 with design changes, complaints, adverse events, CAPA and manufacturing deviations.
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
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 an Engineer/Director. 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 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.
Refund Policy
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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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
