Introduction to the FDA Quality Systems Regulations for Internal Auditors

An ineffective audit can mean severe consequences, resulting in process failure, customer dissatisfaction and regulatory non-compliance.

Optimize your auditing skills with a deeper insight of the FDA Quality Systems Regulations and learn what to look for in a quality management system (QMS) that is compliant with ISO 13485.


Who should attend?

  • Quality Managers
  • Internal Auditors
  • Regulatory Affairs Managers

Note: Knowledge of the FDA Quality Systems Regulations are a prerequisite for this course.

What will I learn?

You will learn about:

  • FDA Quality System Regulation (QSR) requirements
  • What points to consider when auditing the requirements as part of an internal audit in conjunction with ISO 13485

What's included?

  • Training course notes
  • Lunch