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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: Dec 5-8, 2011
Exam: Dec 9, 2011
The Westin Alexandria
400 Courthouse Square
Alexandria, VA 22314
website
866-837-4210
$209 single/double
Reservation ID: AAMI
rate through 11/13/2011
Course: Feb 20-23, 2012
Exam: Feb 24, 2012

The Ritz-Carlton, Georgetown
3100 South Street NW
Washington, D.C.  20007
website

202-912-4100
$199 single/double
rate through 1/23/2012
Course: Apr 23-26, 2012
Exam: Apr 27, 2012
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 3/23/2012
Course: Jun 11-14, 2012
Exam: Jun 15, 2012
Walt Disney World Swan and Dolphin 1200 Epcot Resorts Boulevard
Lake Buena Vista, FL 32830
website
800-227-1500
407-934-4000
$189 single/double
Reservation ID: AAMI
rate through 5/13/2012
Course: Sep 17-20, 2012
Exam: Sep 21, 2012
The Westin Alexandria
400 Courthouse Square
Alexandria, VA 22314
website
866-837-4210
$209 single/double
Reservation ID: AAMI
rate through 8/26/2012
Course: Oct 8-11, 2012
Exam: October 12, 2012

Conrad Dublin
Earlsfort Terrace
Dublin, 2 Ireland
website

Tel: 353-1-602-8900
169 euro for single room
179 euro for double room
rate through 8/8/2012

Course: Dec 3-6, 2012
Exam: Dec 7, 2012
The Westin Alexandria
400 Courthouse Square
Alexandria, VA 22314
website
866-837-4210
$209 single/double
Reservation ID: AAMI
rate through 11/11/2012
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
8:00 AM-5:00 PM
FDA Inspectional Approach-QSIT- 2 hrs
Overview & Management - 4 hrs

Document Cntrls & Records - 2 hrs
DAY 2
8:00 AM-5:00 PM
Design Controls - 8 hrs
DAY 3
8:00 AM-5:00 PM
Acceptance Activities - 3 hrs
Production and Process Controls - 5 hrs
DAY 4
8:00 AM-5:00 PM
Production and Process Controls (cont.) - 2½ hrs
Monitoring and Feedback - 5½ hrs
DAY 5
8:00 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 2½ hour 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 2½ 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, 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
2012 FEES
AAMI Corporate & Institutional Members
$2185
AAMI Individual Members
$2485
Nonmembers
$2785
Government Employees
$785
EXAM (FRIDAY MORNING) includes continental breakfast
2012 FEES
AAMI Members
$250
Nonmembers
$350
Government Employees
$150

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