RISK MANAGEMENT FOR MEDICAL DEVICE BUSINESSES, PROCESSES, AND PRODUCTS

ASQ-Biomedical Division

RISK MANAGEMENT FOR MEDICAL DEVICE BUSINESSES, PROCESSES, AND PRODUCTS


Embassy Suites Baltimore - at BWI Airport 1300 Concourse Drive Linthicum, MD 21090	Monday, Oct. 22, 2007 - Tuesday, Oct. 23, 2007 8:00 AM - 4:30 PM

Details

The ASQ Biomedical Division presents
RISK MANAGEMENT FOR MEDICAL DEVICE BUSINESSES, PROCESSES, AND PRODUCTS
A two-day Seminar with Workshops
Monday and Tuesday, October 22 and 23, 2007
Embassy Suites Baltimore at Baltimore/Washington International (BWI) Airport

Join experts from government, industry, and academia for the latest thinking on the application of risk management to medical device businesses and related topics. Gain insight into recent, important changes to regulatory standards and guidance for enterprises, products, and processes. This comprehensive seminar presents risk management concepts used throughout the business including the quality system and the lifecycle of the product, from design...to manufacturing... through post-production.

Topics will include:

Enterprise and Business Risk Management
Communicating Product and Compliance Risks to Top Management
The important changes to GHTF approaches to Risk Management
The important changes to IEC 60601
The important changes in MEDDEV 2.12-1 rev 5, MEDICAL DEVICES VIGILANCE SYSTEM
The important differences in ISO 14971:2000 and 14971:2007
Using Risk Management to Improve Software development and deployment TIR-32
Risk Management in Production and Process Control
Risk Management in Outsourcing, Purchasing Controls, and Acceptance Activities
Integrating Risk Management in Complaint Handling and in CAPA
Risk Management Tools including FTA, FMEA

Confirmed Speakers include:
Kimberly Trautman, Quality Systems Expert, CDRH, FDA
Alf Dolan, Associate Professor, University of Toronto
Kenneth Imler, Vice President RA/QA, Arrow International
Angelo Scangas, Quality Support Group, Inc.
Oliver Christ, General Manager, PROSYSTEM AG
Andre Routh, Ph.D., Sr. Product Expert, BSI Product Services-Healthcare
Bill McLain, Principal Consultant, Keystone Regulatory Services, LLC
Glen Emelock, The CRO Group, Inc.
Pam Goldstein, GI Dynamics
Debbie Iampietro, QRC Associates
Paul Meixner, Thomas Medical Products, Inc.
F. David Rothkopf, MEDIcept

ASQ members $795
Forum and non-members $ 995
Click here and join ASQ as a full member for $125 and SAVE
Event Price includes Breakfast, Breaks, Lunch, Presentation Handouts,
and a copy of TIR-32 Medical Device Software Risk Management

Make your hotel reservations today!
Click here
or call 410-850-0747 or 1-800-EMBASSY (800-362-2779)-

Not Available for Booking

None of these items are bookable

ASQ-Biomedical Division Purchase/refund policy: Cancellation Policy: You will receive a full refund if you cancel your reservation two weeks or more before the event. Within two weeks of the event, we will offer a full refund only if a replacement attendee can be secured, either by you or from our standby list. No refunds will be given for no shows.

Acteva's Purchase/refund policy: Refunds and cancellations are provided only at the discretion of the organization hosting or sponsoring this event. Acteva, Inc. issues credits only when directed to do so by the sponsoring organization. Contact the sponsoring organization for further details.

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