Registration 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 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 receive a certificate stating they participated in the course and passed the exam.
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.
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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, 2nd ed., 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 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. Click here to go to registration.
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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
Fees
include course textbook, The Quality System Compendium, 2nd ed.; participant notebook of course materials and case studies; pertinent FDA documents and additional references; welcome reception; and continental breakfast, lunch, and refreshments for four days.
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