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 is given following each class.
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.
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 | ||
| DAY 1 8:00 AM-5:00 PM |
FDA
Inspectional Approach-QSIT- 2 hrs Overview & Management - 4 hrs Document Cntrls & Records - 2 hrs |
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| 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 |
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| DAY 4 8:00 AM-5:00 PM |
Production
and Process Controls
(cont.) -
2½ hrs Monitoring and Feedback - 5½ hrs |
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| DAY 5 8:00 AM-11:00 AM |
Optional Examination - 2½ hrs | |
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
Fees
Fees
include course textbook, The Quality System Compendium; 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. Click here to go to registration.
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