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?
Upon completion of the training, you will:
- 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
Who should attend?
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.
What will I learn?
- 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
What is included?
- Delegate workbook
- Lunch and refreshments (Applicable for classroom only)
- On completion, you'll be awarded an internationally recognized BSI Training Academy certificate
