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Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency

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On-Site / Seminar

Details

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.

Outline

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

Speaker/s

Stan Mastrangelo
Consultant

Stan Mastrangelo has over 30 years of professional work experience in Quality Assurance of medical devices, pharmaceuticals, and foods. Stan has held positions such as Senior Quality Engineer, Corporate Quality Assurance Auditor, Plant QA Manager, QA Director, and Consultant. Stan was a member of the ANSI Executive Standards Board. Stan has had extensive involvement in the development of International Risk Management Standards. Stan was a member of the ISO Joint Working Group for Risk Management of Medical Devices (that developed ISO/IEC14971). Stan was a committee liaison to the ISO Technical Management Board Joint Working Group on Risk Management that developed ISO 31000 which is the Risk Management Standard for all sectors. Stan was on the US PhRMA (Pharmaceutical Research and Manufacturers Association) Team that supported the development of ICH (International Conference for Harmonization) Standard Q9 titled Quality Risk Management for Pharmaceuticals. Stan also served on various IEC Standards Teams related to IEC 60601, IEC 80001 and Risk Management in the Software Lifecycle. Stan is an Adjunct Professor at Virginia Tech and was a co-developer of a Masters Degree Program in Medical Product Risk Management. Stan is on the Risk Management Committee for the IECEE.

Special Offer

For Registrationhttp://www.complianceonline.com/iso-14971-medical-device-risk-management-a-to-z-best-practices-seminar-training-80076SEM-prdsm?channel=speedycourse          

 

Note: Use coupon code  NB5SQH8N  and get 10% off on registration.
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