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EduNeering Launches New Curriculum for Quality Systems Regulations (QSR)

Courses Developed with the FDA under the CRADA

October 5, 2006 - Princeton, New Jersey - EduNeering, the leading provider of compliance knowledge management solutions which assure regulatory compliance and improve business performance, in collaboration with the U.S. Food and Drug Administration (FDA), 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 extensive library of compliance courses within the FDA's Office of Regulatory Affairs (ORA) virtual university, ORA U, and will be available exclusively to EduNeering's clients.

The new QSR curriculum, co-developed by EduNeering and the FDA, include 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 manufacturer's 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 FDA's 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 FDA's 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 co-developed more than 100 web-based learning activities and courses for ORA U.

The same solution developed under the CRADA is used by EduNeering's life sciences clients, both regulated industry and governmental agencies, including the US Air Force, the US Army, and Veterans Affairs as well as leading pharmaceutical, biologics and medical device clients around the world.

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EduNeering (www.eduneering.com), a Deloitte Technology Fast 500 Company, develops technology-enabled knowledge solutions for improving business performance and assuring regulatory compliance. For more than 25 years, the company has served corporate and government clients in the life sciences, healthcare, energy and industrial sectors using proprietary platforms that integrate business, learning and technology. Additionally, EduNeering maintains several unique partnerships with its clients, including a Cooperative Research and Development Agreement with FDA. Headquartered in Princeton, NJ, EduNeering Holdings, Inc. has offices in Houston, TX; Bloomsburg, PA; and the UK.