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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.
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)
For complete conference, pricing and hotel information go to: