EduNeering Launches New Curriculum for Quality Systems Regulations (QSR)
EduNeering (www.eduneering.com), has developed a new curriculum of courses on Quality Systems
Regulations (QSR). The new QSR series of courses, authored by the FDA, will be added to the library of
compliance courses within the FDAs Office of Regulatory Affairs (ORA) virtual university, ORA U,
and will be available exclusively to EduNeerings clients.
The new QSR curriculum, co-developed by EduNeering and the FDA, includes 11 new
web-based courses emphasizing topics in the area of Quality Systems Regulations (QSR),
including:
¢ Quality System Regulations
¢ Design Controls
¢ Identification and Traceability
¢ Acceptance Activities--Nonconforming Product
¢ Corrective and Preventive Action
¢ Labeling and Packaging Control
¢ Application of QSR requirements within a medical device manufacturers quality system
Additionally, a new series of courses on the Foundations of Medical Device Regulations
will be available later this fall.
ORA U, the virtual university, provided by EduNeering under the terms of a Cooperative
Research and Development Agreement (CRADA), is used by the FDA to educate and certify
their enforcement investigators as well as FDA-authorized state and local personnel performing
inspections of regulated pharmaceutical, medical device, biologics and food industries. The
new QSR curriculum reflect the FDAs most current requirements, priorities, and policies in the
areas of quality systems, import operations, medical device regulations, and drug safety.
"Our ongoing collaboration with the FDA enables the agency to accelerate, improve and
standardize the proficiency and certification of investigators," said Dr. Donald A. Deieso,
President and CEO of EduNeering. "With third-party inspection programs, bi-lateral
agreements, and foreign agencies having greater roles in the FDAs inspection process, the
need for consistent, current and accurate knowledge among all parties takes on ever increasing
importance. Also, we are confident that these courses will also provide important
technical background for employees within the drug, medical device, and biologics industry."
EduNeering was selected by the FDA for participation in a Cooperative Research and
Development Agreement (CRADA), the first of its kind. Under the CRADA, EduNeering
developed and continues to manage and expand ORA U, which the FDA has used to educate
more than 30,000 inspectors and investigators. To date, EduNeering and the FDA have codeveloped
more than 100 web-based learning activities and courses for ORA U.
