This intensive 4-day program provides quality system professionals with the basic knowledge and skills needed to develop a quality system program that conforms with the FDA's Quality System regulation. Course content is the culmination of almost two years of consensus development on the part of a respected group of more than thirty quality system experts from leading device manufacturing companies, the FDA, and consultants to the industry. 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.

An optional 2.5 hour exam, immediately following each course, is administered to test mastery of the course materials and ability to interpret the regulation correctly.

Format
This program offers FDA and industry the unique opportunity to participate in a shared learning experience. Recent participants have cited the FDA-industry interaction — including the opportunity to hear firsthand FDA interpretations and expectations — as the most valuable aspect of this program. Course attendees have also benefited from exchanging experiences with their peers and expert instructors through discussions and case study analysis.

Dates & Hotels

DATES LOCATION PHONE & RATES Course: Jun 16-19, 2008 Exam: Jun 20, 2008 Loews Denver Hotel 4150 East Mississippi Avenue Denver, CO 80246 Website 800-345-9172 / 303-782-9300 $199 single/double rate through May 19, 2008 Course: Sep 22-25, 2008 Exam: Sep 26, 2008 Paradise Point Resort & Spa 1404 Vacation Road San Diego, CA 92109 Website 800-344-2626 / 858-274-4630 $199 single/double Reservation ID: AAMI rate through Aug 24, 2008 Course: Oct 20-23, 2008 Exam: Oct 24, 2008 London Marriott Maida Vale Plaza Parade Maida Vale London, NW6 5RP Website 44 80 0221 222 £105 B&B single £115 B&B double rate through Sep 8, 2008 Course: Dec 8-11, 2008 Exam: Dec 12, 2008 The Westin Arlington Gateway * 801 North Glebe Road Arlington, VA 22203 Website 888-627-7076 / 703-717-6200 $199 single/double rate through Nov 12, 2008 NOTE: Reservation requests should be made as soon as possible, but no later than the "rate through" date above. Rooms are assigned on a first-come, first served basis and may sell out prior to the deadline. * Due to the number of events that AAMI is holding at The Westin Arlington Gateway in 2008, it is necessary to specify which course you are attending when making your room reservation.

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. To maximize the peer learning opportunity, AAMI recommends this course for those who already have a basic understanding of the FDA's Quality System requirements, including direct work experience. Past course attendees have included representatives from industry, quality systems consulting, and the FDA. To date, over 200 FDA employees from the Center for Devices and Radiological Health and the field have completed the AAMI course.

Objective
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.

Faculty
All course faculty have completed an instructor training program. On-going peer and participant evaluation ensure consistency and quality from course to course. The faculty team for each program includes a lead instructor, a representative from the FDA, and a quality system expert from industry. The mix of industry leaders, consultants, and FDA personnel helps to ensure a balanced presentation of the requirements and paths to compliance.

Program-At-A-Glance
Quality System Requirements and Industry Practice consists of three components: the textbook entitled The Quality System Compendium, 2ed. , a four-day course, and an optional 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 situation 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.

Examination
An optional 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 stating they participated in the course and passed the exam. For additional information about the exam, email education@aami.org.

Registration Fees
Fee includes course textbook, The Quality System Compendium; course materials; welcome reception; and continental breakfast, lunch, and refreshments for four days.

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