Developing, establishing, and validating a compliant and successful quality management system means that you and your company must understand the differences, similarities, and synergies between international industry standards and regulations.  ANSI/AAMI/ISO 13485:2003 is a world-wide standard for medical device companies, and the FDA Quality System regulation is the directive that medical device companies must comply with in order to conduct business in the United States.  Both the standard and the regulation have complementary, process-based architectures that work well together to enable device-related companies to not only be compliant with regulatory agencies but also realize business-oriented success with their valued customers.  If your medical device company has decided to gain certification to 13485, your FDA-compliant quality management system and culture must be adjusted to simultaneously adhere to both.

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
The primary objective of the workshop is to prepare participants to successfully implement and maintain a quality management system that complies with 13485 and the Quality System regulation at their companies.  The workshop will also provide practical information related to:

• Objectives of 13485 and the facilitation of related guidance documents
• Use of ANSI/AAMI/ISO TIR14969:2004 and the Preamble to the Quality System regulation as guides for building ISO and Quality System related processes
• Use of process orientation for compliance as well as an effective tool for daily operations and regulatory acuity
• Similarities and differences between 13485 and the Quality System regulation and how they compliment each other for success
• Use of process mapping, compliance schematics, and the applications-based approach for building quality systems and improving operational processes
• Process for achieving certification to 13485 and a general preparedness for Quality System regulation scrutiny

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.

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?
Instruction is targeted to professionals, both implementers and users, involved in meeting FDA's Quality System requirements such as those in regulatory affairs, quality assurance, process development, or manufacturing.  To maximize the learning experience, this workshop has been designed for those who already have a basic understanding of the architecture of quality systems. 

Dates & Hotels

DATES LOCATION PHONE & RATES November 3-5, 2008 The Westin Gaslamp Quarter, San Diego 910 Broadway Circle San Diego, CA 92101 Website 800-937-8461 / 619-239-2200 $199 single/double rate through October 3, 2008 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.

Registration Fees
Fee includes course materials; continental breakfast and refreshment breaks for three days; and lunch for first two days of the course.

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