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ASQ Biomedical Division National Conference  

Hilton Alexandria Mark Center
5000 Seminary Road
Alexandria, Virginia  22311

Oct 5, 2006    8:00 am - 5:00 pm
Oct 6, 2006    8:00 am - 5:00 pm

October 5 - 6, 2006

This one time repeat of the sold-out March 2006 event offers our attendees a truly unique speaker line-up addressing topics and issues essential to you and your company's success. Attendees will interact directly with FDA and Notified Body personnel along with proven industry experts who will share knowledge and tools vital to meeting today's expectations of the Medical Device Quality Professional.

Speakers & Topics include:

Ken Kopesky, Vice President of Corporate Quality, Compliance and Audit; Medtronic, Inc.
Personal Experiences: Managing Quality in a Complex Organization

Kimberly Trautman (invited) , FDA's Expert on GMP/Medical Device Quality Systems
FDA Update: The NEW CPG Compliance Policy Guide on inspections, QS Warning Letter trends, and GHTF update on Risk Management implementation within a Quality Management System

Paul Brooks, Vice President Product Services, BSI EU (British Standards Institute)
ISO 13485:2003-Implementation Obstacles and Common Areas of Concern

F. David Rothkopf, President, MEDIcept, Inc.
Integrating CAPA and Risk Management into the Product Life Cycle

Bruce Haggar, President, MedQ Systems, Inc. and Steven Walfish, President, Statistical Outsourcing Sevices
Workshop: Process Characterization and Six Sigma for Medical Devices

Rita Wadleigh, Quality Assurance and Regulatory Affairs Manager, Luxtec, A Division of LXU Healthcare, Inc.
Effective Auditing

A. Arthur Rankis, President, A. A. Rankis & Associates
Supplier Management- What's New, What's Working, What's Not

Susan C. Reilly, President, Reilly & Associates
Managing an FDA Inspection

Carol Montandon, Vice President, QA/RA and Chief Compliance Officer, Animas Corp. (a Johnson & Johnson company)
Leading Quality

For complete conference, pricing and hotel information go to:

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