Linking Human Factors with FDA's Quality System Regulation: A Critical Component to the Design and Manufacturing Process
During the design and manufacturing process, manufacturers must consider Human Factors in order to make a safe and effective product. To assist your company in understanding how Human Factors relates to the Quality System regulation, the AAMI offers this two-hour webinar CD, Linking Human Factors with FDA's Quality System Regulation: A Critical Component to the Design and Manufacturing Process.
This CD provides you with information on how to integrate Human Factors Engineering into the quality system, clarification on how to validate and verify human factors design at different stages of the product development cycle, and a better understanding of FDA expectations on identification and analysis of use error and risk management.
You'll have the opportunity to hear directly from industry and FDA and listen to questions and answers from the live broadcast.
PROGRAM-AT-A-GLANCE
- Explains the importance of Human Factors engineering for medical devices.
- Provides information on documentation of Human Factors Engineering deliverables.
- Offers tips on the best methods for verification of Human Factors design.
- Presents a case study demonstrating how to incorporate Human Factors Engineering in the design.
- Examines common pitfalls that device manufacturers encounter when doing Human Factors.
SPEAKERS
- Ed Israelski, Abbott Laboratories
- Peter Carstensen, Senior Systems & Human Factors Engineer, Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA)
- Ron Kaye, Human Factors Specialist, Center for Devices and Radiological Health, US Food and Drug Administration (FDA)
WEBINAR CD
- Includes handout material and CD
- $245 for webinar registrants/ $345 for non-registrants
- Please note that domestic and international shipping rates apply
THREE WAYS TO ORDER
- Phone - 1-877-249-8226 / 240-646-7031 to order with credit card.
- Fax - Select and download the order form and fax to 240-396-5781 .
- Mail - Select and download the order form and mail with payment to:
Human Factors Webinar CD Package
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For questions about ordering the CD, please contact AAMI Publications at 1-877-249-8226 / 240-646-7031.