Recorded November 22,
2005
Ed Kimmelman, Convenor ISO 13485 Working Group,
recently presented an audio conference to US medical device firms. The
subject was the actions that firms can take to meet some of the
challenges in implementing 13485, QSR, and risk management. The audio conference
received some of the most positive reviews that we've seen.
In response to requests for this program for
European audiences, Ed has agreed to deliver this interactive audio conference
at 1:00 - 2:30 pm GMT (8:00 - 9:30 am EST) on November 22, 2005.
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Audio Conference Recording
Meeting the Challenges in Implementing
ISO 13485, QSR and Risk Management
What You Will Learn:
* The current state of the adoption of ISO 13485:2003 around the world.
* The main ways the US Quality System Regulation and ISO 13485:2003 differ.
* The quality system processes that create the biggest compliance challenges.
* Practical ways of meeting those challenges.
* Risk management issues that arise throughout the quality management system.
* Suggestions for dealing with these issues.
What You Will Get:
* The slides used during the interactive discussion.
* A matrix comparing the requirements of the US Quality System Regulation and
ISO 13485:2003.
* The latest public draft of the GHTF guidance document, SG/N15,
"Implementation of risk management principles and activities within a
quality management system".
About Your Presenter
Ed Kimmelman has over thirty years of industry experience, holding operational,
product and quality management, and executive management positions in the DuPont
Co. and Roche Diagnostics. As convenor of the ISO Technical Committee,
Working Group 1, he led the efforts of an international team that authored ISO
13485. He authored and currently teaches the AAMI course on ISO
13485. Since 1998, Ed, as an independent consultant, has helped numerous
large and small medical device organizations identify and correct quality
management system deficiencies.
What is an Audio
Conference Recording?
An audio conference is an interactive lecture delivered over the
telephone. We offer an audio recording of the conference accompanied by a Power Point Presentation to which the speaker
referred.
Cost:
The audio CD plus the conference
materials is
available for $95.
For questions about the audio CD, contact
Nan Matthews at nan@themattgrp.com
or 1-303-843-6414
For questions about the audio conference
contact
nancy@compliance-alliance.com
or 1-703-525-4159
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