Understanding of FDA 21 CFR part 820 – quality system regulation

Duration 2 days

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This two day training course will give you a good understanding of the FDA 21 CFR 820, Quality System Regulation (QSR).

The medical device industry is highly regulated due to the product risk to health, and one of the requirements is to establish and maintain a quality management system. Although the rest of the world complies with ISO 13485 standard, the United States requires compliance to the 21 CFR 820, Quality System Regulation (QSR).

The QSR, specifying current Good Manufacturing Practices for medical devices, was established in 1997 based on earlier structure of ISO 9001 and ISO 13485, as well as the EN 46001 standards. Although ISO 9001 and ISO 13485 were restructured recently (2015 and 2016), the QSR structure remains unchanged, thus fairly different from the requirements. Besides the structure, there are terms and specific requirements of the QSR which are not in the ISO standards.

Understanding the QSR is essential to ensure compliance to the United States regulatory requirements and to prepare for an eventual visit from the FDA.

How will I benefit?

Have a good understanding of the expectations of the FDA 21 CFR Part 820
Have the knowledge to apply the requirements and ensure compliance
Feel more confident about an FDA inspection

Our tutors have professional experience working with organizations to help them with medical device compliance. They understand your challenges and they bring the subject matter to life with relevant and contemporary examples to enhance your learning.

- Overview of the FDA and intention of the 21 CFR Part 820
- 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
- Ability to prepare and host an FDA inspection
This programme 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.
This training course is HRDF approved under the SBL scheme.

On completion, you will be awarded an internationally recognized BSI Training Academy certificate.

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