Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency (Dec, 2015)

Course Description:

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:

1.Understand what are the current issues and recommended solutions
2.How to implement the ISO 14971 framework
3.Use a Traceability Report for improved risk management operations
4.How to Use Standards to Facilitate Product-to-Market Achievements
5.How to Use Risk Management to Identify the Critical Success Factors
6.Key implementation issues related to Risk Management
7.Using Risk Management to identify key opportunities for the organization
8.Risk Integration Issues, especially related to the Quality System and Design Controls
9.Use of appropriate risk management tools beyond FMEA