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Building a Quality Management System in a Regulated Environment: A 13485 Workshop

This 2½ day workshop provides intensive coverage on the synergy between ANSI/AAMI/ISO 13485:2003 and the Quality System regulation, and ways that companies can apply best practices to comply with both. Instruction focuses on the use of process mapping, compliance schematics, and the applications-based approach for building quality systems and improving operational processes.

Objective
Upon completion of the workshop, participants will be able to successfully implement and maintain a quality management system that complies with ANSI/AAMI/ISO 13485:2003 and the Quality System regulation.

Format
This session will rely on a highly interactive format incorporating case studies, situation analyses, and other exercises to model on-the-job application of knowledge and skill.  Participants will also have significant opportunity to ask questions and discuss challenges, solutions, industry "best practices", and real-life situations.

Program At-A-Glance

DAY ONE 8:00 AM-5:00 PM Introduction and Overview of ANSI/AAMI/ISO 13485:2003 The Basis on which ANSI/AAMI/ISO 13485:2003 is Built: An Overarching Introduction to the Process Approach Working with the Key Requirements DAY TWO 8:00 AM-5:00 PM Working with the Key Requirements (continued) DAY THREE 8:00 AM-12:00 PM — 9001:2000 vs. 13485:2003 - An Overarching Comparison for Edification Purposes — Wrap-up

Course Materials
Participants will receive a copy of the standard, ANSI/AAMI/ISO 13485:2003 - Medical devices-Quality management systems-Requirements for regulatory purposes; the technical information report, ANSI/AAMI/ISO TIR14969:2004-Medical devices-Quality management systems-Guidance for the application of ISO 13485:2003; pertinent FDA documents; additional reference materials; and a participant's guide for easy note-taking.

Who Should Attend?
This workshop is for professionals involved in implementing, using, and maintaining a quality management system that complies with ANSI/AAMI/ISO 13485:2003 standard and the Quality System regulation. To maximize the learning experience, this workshop has been designed for those in regulatory affairs, quality assurance, process development, or manufacturing who already have a basic understanding of the architecture of quality systems.

Dates & Hotels

DATES LOCATION PHONE & RATES October 12-14 , 2009 The Westin Arlington Gateway 801 North Glebe Road Arlington, VA 22203 Website 888-627-7076 / 703-717-6200 $209 single/double rate through Sep 14, 2009 NOTE: Reservation requests 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.

Faculty
Course faculty are drawn from an experienced group of quality systems professionals. All course faculty have completed an instructor training program to ensure consistency and quality from session to session.

Fees and Registration
Fees include the textbook, The Quality System Compendium, 2nd ed., participant notebook of course materials and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments..

REGISTRATION TYPE 2009 FEES AAMI Corporate & Institutional Members $1685 AAMI Individual Members $1785 Nonmembers $2085 Government Employees $585

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MEMBERSHIP TYPE 2009 FEES U.S. Individual Membership Rates $205 Non-U.S. Individual Membership Rates $265

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