|
2-Day In-Person Workshop (January 28 - January 29, 2016)
Integrated Approach to Medical Device Risk Management and Design Controls This seminar focuses on integrating ISO 14971 Risk Management for Medical Devices and 21 CFR 820 Design Controls into your quality system. Robust design and risk management processes anticipate risks and consistently deliver safe and effective medical devices. The FDA and leading medical device manufacturers have increased their emphasis on these processes. ISO 14971 and 21 CFR 820 Design Controls require processes that span the medical device lifecycle. To satisfy that requirement, risk analysis and design controls must be integrated into new product development, design change, manufacturing, CAPA and post market surveillance systems. Integration creates a closed loop system where predictive methods and data based observations are used throughout the device lifecycle to make decisions and guide work. Information is passed back and forth creating cycles of learning that improve device safety, effectiveness and overall device quality. Integrating these system is challenging: Done Poorly - it slow processes, causes confusion and puts you at risk; Done Well - it delivers quality products, resource efficiencies and regulatory compliance that is easily demonstrated. The FDA reports ineffective Risk Management and Design Controls are the root cause of as many as 31% of recalls. You can’t afford to be in a position where these processes are weak. This seminar will explain how to create an integrated risk management and design control system that is effective for your business, customers and satisfies regulatory agencies such as the FDA. |
|
Who will benefit:
This workshop applies to personnel and companies in the medical device and combination products industries. The employees who will benefit most include:
This workshop applies to personnel and companies in the medical device and combination products industries. The employees who will benefit most include:
- Project managers
- Quality managers and staff
- Regulatory and Compliance managers and staff
- R & D, Product Development and Sustaining Engineering, managers and staff
- Design Transfer managers and staff
- Anyone with Product Development, Risk Management, Regulator or Quality Assurance responsibilities
For additional information on the workshop agenda and logistics, please call +1 877-566-4981 or +1 410-501-5777 or email: [email protected]
