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HUM-MOLGEN
-> Events
-> Meetings and Conferences |
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September 11, 2011 |
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global compliance panel, Online Training Webinars
2011-09-22
Why you should attend: There are a variety of tools that can be used in conjunction with the Risk Management activities under ISO 14971. None is more widely used by medical device manufacturers than Failure Modes and Effects Analysis. The tool is a tool designed for reliability however, and has been widely misused in medical device Risk Management. It does not fulfill the requirements for a risk analysis, but it is presented by manufacturers as their "Risk Analysis" when requested by auditors and FDA inspectors.
Areas Covered in the Session:- This presentation will explore the proper use of the FMEA tool in medical device risk management
- The presentation will also discuss how the tool is often misused
- The presentation will include a model for risk analysis using FMEA and other tools
- The tool has limitations as it was developed for reliability purposes
- FMEA does not meet all the required elements of Risk Analysis for medical devices
- A method for properly documentation of risk management activities
Who Will Benefit:- Quality managers responsible for integrating risk management into quality systems
- Quality system auditors
- Regulatory and compliance personnel who develop premarket filings and technical files for medical devices
- Design personnel using risk management during development of new medical devices.
- Manufacturing personnel responsible for process development and validation activities
- Project Managers
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Organized by:
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global compliance panel |
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Invited Speakers:
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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 Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of this group. Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.
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Deadline for Abstracts:
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2011-09-22
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Registration:
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Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00
webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
Phone: 800-447-9407 Fax: 302-288-6884
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E-mail:
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webinars@globalcompliancepanel.com
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Frank S.
Zollmann.
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