This hour-long CBT discusses a high-level understanding of why the Quality System Regulation (QSR) is important and supports your business and compliance drivers. The course provides a breakdown of the QSR requirements and includes subpart detail. It also highlights the differences between FDA and ISO standards. Quality System Regulation is taught as an e-learning course to provide an overview of The Quality System Regulations and ISO 13485. It can be taken through our ePath learning system on a desktop, phone, or tablet.
Explain Why we Follow the FDA QSR
- Explain why we follow the FDA QSR.
- Identify general compliance expectations.
- Identify the key elements of the QSR.
- Explain the key differences between the FDA QSR and ISO Standards.
- Optimize productivity and training time
- Flexible mobile learning using a desktop, laptop, tablet or mobile device
- Fulfill new hire and annual FDA training requirements
QSR training is appropriate for all employees involved in the manufacture or support of the medical device industry.