FDA Quality System Regulations/Medical Device Good Manufacturing Practices / ISO 13485

Course Description
This training course provides a systematic approach to risk management for the medical device industry. It is designed to help participants understand the importance and purpose of ISO 14971 and identify links between ISO 13485 and ISO 14971. Instruction includes training on how risk management applies to the product lifecycle and how to effectively implement the objectives of a risk management process.

Who Should Attend
This course is designed for individuals involved with regulatory issues, quality, design, development, and manufacturing, as well as marketing managers, and internal auditors in the medical device industry.

Learning Objectives
During training, participants will learn how to implement good risk management principles into medical products manufacturing operations, such as medical devices, combination products, and pharmaceuticals.

Course Outline

  • Implementing the ISO 14971 framework
  • 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
  • Risk management tools: FMEA, FTA, Risk Registers
  • Identifying the links between ISO 13485 (QMS) and ISO 14971 (RM)
  • Risk management and the product lifecycle
  • Risk management terminology
  • Stages of the risk management process
  • Key deliverables of the risk management process
  • Evaluating the effectiveness of a risk management program

Course Format
8 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities and on-site at your organization

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