ComplianceOnline, Courtyard by Marriott Chicago Downtown
2019-03-07
The course is designed for Medical Products Manufacturers. The course will be taught for Medical Devices and Combination Products, but will also be of benefit to Pharmaceutical Manufacturers. Learning Objectives:Upon completion of the course, the participants will have learned how to implement good risk management principles into medical products manufacturing operations such as medical devices, combination products, and pharmaceuticals: - Understand what are the current issues and recommended solutions
- How to implement the ISO 14971 framework
- Use a Traceability Report for improved risk management operations
- How to Use Standards to Facilitate Product-to-Market Achievements
- How to Use Risk Management to Identify the Critical Success Factors
- Key implementation issues related to Risk Management
- Using Risk Management to identify key opportunities for the organization
- Risk Integration Issues, especially related to the Quality System and Design Controls
- Use of appropriate risk management tools beyond FMEA
Who will benefit:The course is designed for manufacturing professional employees that must interface with or implement product risk management activities in a medical product manufacturing operation. - Product Risk Managers
- Quality Assurance
- Regulatory Affairs
- Research & Development
- Project Managers
- Operations Managers
- Manufacturing Managers
- Engineers
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