Quality System Requirements & Industry Practice

Industry field:

Medical Device industry

Course description:

This intensive 4-day program provides quality systems professionals with the basic knowledge and skills needed to develop a quality system program that conforms to the FDA’s Quality System regulation. In 1999, this program was selected as part of the mandatory training for European Conformity Assessment Bodies under the US/EU Mutual Recognition Agreement. In 2003 FDA made attendance at the Quality System course part of the training criteria for its Accredited Persons Program.

Learning objectives:

Upon completing this program, participants will be able to examine their quality system to determine if it complies with FDA requirements and recognize where improvements are needed. In addition, this course covers acceptable compliance practices, recognizing that different approaches may apply to various medical device classifications and to company size.

Format:

This program offers the industry the unique opportunity to participate in a shared learning experience. Course attendees will have the benefit of exchanging experiences with their peers and expert instructors through discussions and case study analysis.

Program At-A-Glance:

Quality System Requirements and Industry Practice consists of three components: the textbooks entitled The Quality System Compendium and The Supplement to the Quality System Compendium, a four-day course, and a 2.5 hour examination. Although this is a comprehensive learning experience covering all aspects of FDA’s Quality System requirements, course content focuses on those areas of the regulation that are new, or have traditionally been the most problematic in interpretation. Aspects such as design control and process validation are covered extensively.

A combination of situational analyses, case study exercises, review of sample recall and warning letters, and both formal and informal discussions are used throughout the program to provide maximum opportunity for the application of information and learning.

See the detailed Course Outline (PDF) here »

Who should attend:

The course and exam are essential requirements for quality system experts. Instruction is targeted to professionals directly involved in meeting FDA’s Quality System requirements or those who are ultimately responsible for compliance. Past course attendees have included representatives from industry, quality systems consulting, and the U.S. FDA. To date, over 200 FDA employees have completed this course.

Examination:

A 2.5 hour exam to test mastery of the course materials and ability to correctly interpret the Quality System regulation is conducted on the last day of the program. A group of quality system industry and regulatory experts, including FDA representatives, developed and reviewed the exam questions. Only current and past attendees will be eligible to sit for the exam. Those who pass the exam will receive a certificate of achievement.

Course facts

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