Conference 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:

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