Quality Systems for Medical Devices

Training Duration: 4 days

This course covers FDA’s Quality System Regulation (21CFR820). The course should be standard training for all employees in the medical device industry who have job functions in quality, production, laboratories, facilities/ equipment, validation and product development. With FDA’s focus on management controls, this course also should be a prerequisite for entry into management positions.

Training Features

  • Content focuses on the QSR (CFR:820) federal regulation.
  • It explain in detail the purpose of each individual element of the regulation.
  • Examples on how to comply with each element.
  • Information on what to expect during FDA Quality System inspections.

Training Benefits

  • New employees will have a clear understanding of the industry governing regulations.
  • Employees will have and increase knowledge of how the regulations affects their specific job responsibilities.
  • Employee increase performance, less mistakes due to lack of basic understanding of the regulations.

International Quality Consulting bring a diverse team of consultants to our clients. We are constantly expanding our roster of internationally recognized associates. Our trainers and consultants average over 30 years experience in the FDA regulated environment – many of which are ex-FDA. Our associates bring a wealth of experience to help meet your consulting and training needs.

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