Understanding of FDA 21 CRF Part 820 Quality System Regulation Training

Understanding of FDA 21 CRF Part 820 Quality System Regulation Training

Understanding of FDA 21 CRF Part 820 Quality System Regulation Training

Course Objective:

  • Overview of the FDA and intention of the 21 CFR Part 820
  • To understand the up-to-date requirements of 21 CFR Part 820 and other Parts such as Part 11, Part 803 and Part 821
  • Working knowledge in application of the requirements
  • Preparation for FDA inspection

Course Highlight:

This course provide an overview of the FDA 21 CFR Part 820 Quality System Regulation requirements.
Example of the implementation would be discussed during the training.

This course covering the topics indicated below:
  • Introduction of FDA
  • Overview of 21 CFR Part 820
  • 21 CFR Part 820 - Quality System Regulation
  • 21 CFR Part 11, Part 830 and Part 821
  • Registering with US FDA and FDA Inspection

Duration:

2 days

Suitable for:

This course is designed for ALL functions and levels of an organization who need to gain some basic understanding of the US FDA 21 CFR Part 820 requirements. A value-added course for those working with regulatory compliance and involved in regulatory inspection.

Contact us for the synopsis.



Understanding of FDA 21 CRF Part 820 Quality System Regulation Training

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