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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.
DAY ONE
8:00
AM-5:00 PM |
FDA
Inspectional Approach-QSIT - 2 hrs
Overview and Management - 4 hrs
Documents and Records - 2 hrs |
DAY TWO
8:00
AM-5:00 PM |
Design
Controls - 8 hrs
|
DAY THREE
8:00
AM-5:00 PM |
Acceptance
Activities - 3 hrs
Production
and Process Controls - 5 hrs |
DAY FOUR
8:00 AM-5:00 PM |
Production
and Process Controls
(continued) - 2.5 hrs
Monitoring
and Feedback - 5.5 hrs |
DAY FIVE
8:00
AM-11:00 AM |
Optional
Examination - 2.5 hrs |
|
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.
| REGISTRATION
TYPE |
2008
FEES |
| AAMI
Corporate & Institutional Members |
$2085 |
| AAMI
Individual Members |
$2385 |
| Nonmembers |
$2685 |
| Government
Employees |
$685 |
| EXAM
(FRIDAY MORNING) |
2008
FEES
|
| AAMI
Members |
$225
|
| Nonmembers |
$325
|
| Government
Employees |
$125
|
|
Join
AAMI and Save!! Link to Membership
| MEMBERSHIP
TYPE |
2008
FEES |
| U.S.
Individual Membership Rates |
$200 |
| Non-U.S.
Individual Membership Rates |
$260 |
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