Quality System Requirements and Industry Practice
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 half day exam is given following each class.
Format
This program offers FDA and industry the unique opportunity to participate in a shared learning environment. Course attendees have cited the exchange of experiences with their peers and expert instructors, through discussions and case study analysis, as one of the most valuable aspects of this program.
Dates & Hotels
| DATES | LOCATION | PHONE & RATES |
| Course: June 17-20, 2013 Exam: June 21, 2013 FULL |
San Francisco Marriott Fisherman's Wharf 1250 Columbus Avenue San Francisco, CA 94135 Website |
800-525-0956 | 415-775-7555 $204 single/double Rate through 5/20/2013 |
| Course: Sept 9-12, 2013 Exam: Sept 13, 2013 |
Hotel Novotel Amsterdam City Europaboulevard 10 1083 AD AMSTERDAM Amsterdam, Netherlands Website |
(+31)20/7219179 €135 for 9/8-9/11/2013 €189 for 9/12/2013 Rate through 7/12/2013 |
| Course: Sept 23-26, 2013 Exam: Sept 27, 2013 |
The Westin Arlington Gateway 801 North Glebe Road Arlington, VA 22203 Website |
703-717-6200 $209 single/double Reservation ID: AAMI Rate through 8/25/2013 |
| Course: Oct 28-31, 2013 Exam: Nov 1, 2013  |
Red Rock Casino Resort Spa 11011 West Charleston Boulevard Las Vegas, NV 89135 Website |
866-767-7773 | 702-797-7777 $140 single/double Rate through 10/6/2013 |
| Course: Dec 9-12, 2013 Exam: Dec 13, 2013 |
The Westin Alexandria 400 Courthouse Square Alexandria, VA 22314 Website |
866-837-4210 $209 single/double Reservation ID: AAMI Rate through 11/10/2013 |
| NOTE: Reservation request should be made as soon as possible, but no later than the 'rate through' date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline. | ||
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.
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 and a quality system expert from industry. The mix of industry leaders and consultants helps to ensure a balanced presentation of the requirements and paths to compliance.
Program-At-A-Glance
| PROGRAM | ||
| DAY 1 8 AM-5:00 PM |
FDA
Inspectional Approach-QSIT- 2 hrs Overview & Management - 4 hrs Document Cntrls & Records - 2 hrs |
|
| DAY 2 8 AM-5:00 PM |
Design Controls - 8 hrs | |
| DAY 3 8 AM-5:00 PM |
Acceptance
Activities - 3 hrs Production and Process Controls - 5 hrs |
|
| DAY 4 8 AM-5:00 PM |
Production
and Process Controls -
2.5 hrs Monitoring and Feedback - 5.5 hrs |
|
| DAY 5 8 AM-11:00 AM |
Optional Examination | |
Quality System Requirements and Industry Practice consists of three components: the textbook entitled The Quality System Compendium, 2nd ed., a four day course, and an optional 2 ½hour examination. Although this is a comprehensive learning experience covering all aspects of FDA's Quality System requirements, course content emphasizes those areas that traditionally have 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 ½hour 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, e-mail education@aami.org.
Registration Fee
Fee includes the textbook, The Quality System Compendium; PowerPoint presentations and case studies; pertinent FDA documents and additional references; welcome reception; and continental breakfast, lunch, and refreshments for four days. Click here to go to registration.
| REGISTRATION TYPE | FEES |
| AAMI Corporate & Institutional Members | $2185 |
| AAMI Individual Members | $2485 |
| Nonmembers | $2785 |
| Government Employees | $785 |
| EXAM (FRIDAY MORNING) includes continental breakfast | |
| AAMI Members | $250 |
| Nonmembers | $350 |
| Government Employees | $150 |