Training Course in FDA’s Medical Device Quality System Regulation

Maintenance procedures have evolved significantly over time, and the necessary equipment has been developed to enhance these processes. Initially, maintenance focused on improving machine performance without considering the potential economic benefits. However, modern advancements have shifted this focus toward better planning, management methods, and quality technology in maintenance. The advent of the technological age has introduced more electronic control machines, greatly impacting maintenance work. This course offers a training course in modern maintenance techniques, utilizing data processing systems and computer-based curricula designed by the academy.

By the end of the course, participants will be able to:

This course offers this course to the following categories:

• Those who need to understand and apply the requirements of the QSR, including R&D managers; engineering managers; management representatives.
• Product, project, and program managers; RA/QA managers/engineers.
• Internal auditors; and other cross-functional team members.

After completing the program, participants will be able to master the following topics:

• Analyze the meaning of the elements of the QSR.
• Understand the purpose, benefits, and objectives of FDA’s Medical Device Quality System Regulation (QSR).
• Compare the relationship between standards and guidance documents in support of FDA compliance initiatives.
• Learn how to read FDA warning letters.
• Recognize situations that warrant warning for QSR deficiencies.
• Map the requirements of the QSR
• Establish audit evidence to support FDA compliance.