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.
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:
Objectives of the Presentation:
- 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
The seminar will present:
Who can Benefit:
- 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)
- 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