Understanding the Scope of Quality System Regulation

In an era of rapid pharmaceutical and biotechnological change, the FDA has a responsibility to the public to continually monitor and refine its standards of compliance for manufacturers of medical devices, drugs and treatments.

This focus on health and safety is at the heart of the operation of every pharmaceutical company in the U.S., but how can large firms keep up with the fast pace of updates to quality system regulation standards, especially with devices and treatments currently in development?

Our Quality System Regulation (QSR) Certified Compliance Professional™ program ensures that you and your associates not only learn the latest regulatory compliance measures, but also understand the full scope of quality system regulation from initial design controls to creating Corrective and Preventive Action Plans (CAPA).

The program is designed to be flexible and tailored to your company’s needs. With many courses tailored to professionals in the medical device manufacturing field, there is also a focus on the FDA’s updated inspection policies, their adoption of lean methods, and reducing the reporting burden on continuous manufacturing to convert from a traditional stepwise model into a single process.

There is also the intention to update and streamline the quality system regulation reporting process for the manufacture of medical devices, something our instructors and students will surely welcome, and will cover in our many medical devices courses. Our instructors have real-world experience to answer your pressing questions about working in this field, and their up-to-date knowledge about these new regulatory requirements will make you feel comfortable with quality system regulation standards.

To register for the Quality System Regulation (QSR) Certified Compliance Professional™ program or find other courses tailored to your needs as a pharmaceutical professional, visit our Training Courses page. For courses focused on medical devices, visit Medical Device Training Courses .

Sources:

https://www.qualitydigest.com/inside/fda-compliance-article/fda-innovation-spoken-here-111318.html

https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/qualitysystemsregulations/default.htm