The document summarizes an upcoming webinar on recalls of medical devices in the US. It discusses the FDA's perceived failures in recent years that have damaged its reputation and its new efforts to improve its image and response to issues. The webinar will cover how industry should interface with the FDA regarding recalls, potential responses to the public during a recall, analyzing product risks, communicating with the FDA, and preparing public information to protect health. It is aimed at medical device managers and others involved in quality, regulatory compliance, and public relations.

1. Recalls of Medical Devices in the US
December 02, Thursday 10:00 AM PST | 01:00 PM EST
Why Should You Attend:
In the recent past the US FDA has been criticized for its perceived failures in protecting the public from unsafe prod-
ucts. The widely publicized contaminated heparin use in medical products and drug failures such as Vioxxl have
tarnished the image of FDA in its efforts to protect the public health. In response a new Commissioner was appointed
with extensive experience in public health. She has rapidly changed FDA's response patterns to serious events.
The new FDA is working rapidly to improve its image with the public and with Congress in response to its perceived
shortcomings over the past 20 years. This presentation will discuss how industry should interface with FDA in regard to
anticipated recalls. Additionally we will discuss the potential response to the public in the event of a recall. The pri-
mary focus should be on providing a safe product and in the event of a failure to provide correct and complete infor-
mation to protect the public health.
Date: December 02, Thursday 2010
Time: 10:00 AM PST | 01:00 PM EST
Duration: 90 Min
Instructor: Edwin L Bills
Location: Your office or conference room (no need to travel!)
Why Should You Attend:
• Recent product recall failures.
• Analyzing product risks.
• CAPA prioritization.
• Communicating with FDA.
• Deciding on the response.
• Preparing the public information.
• Notifying the customers.
Edwin L Bills
Register Now

2. Who Will Benefit:
• Medical Device managers
• CAPA Managers
• Quality Managers
• Regulatory Compliance Managers
• Product Management
• Public Relations personnel
• Marketing Management
Instructor Profile:
Edwin L. Bills, During his 20 year career in medical devices, Mr. Bills has held a number of quality and
regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of
Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the
Regulatory Affairs Professionals Society, and a BS and Masters degree from the University of Cincinnati.
Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumen-
tation committee, QM/WG04, on application of risk management to medical devices and is a current member
of this group.
Registration Information:
* Register Online. Use your American Express, Visa or MasterCard.
* For more than one attendee get 20% off on the price of additional attendee.
* Get your group to attend the webinar at a discounted price call +1- 650-620-3937.
* Call +1 - 650-620-3937 or Fax your PO: 650-963-2556.
* Mail your check to: ComplianceOnline (MetricStream, Inc), 2600 E. Bayshore Road, Palo Alto, CA 94303.
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