2014 - Integrating ISO 14971 Risk Analysis Into the Product Development Process

Instructor: Russell Pizzuto
Description:
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.
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
Register Now:
http://www.onlinecompliancepanel.com/ecommerce/web...
Online Compliance Panel LLC
38868 Salmon Ter
Fremont, CA, USA
94536
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