home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
  HUM-MOLGEN -> Events -> Meetings and Conferences  

FMEA and Risk Management for Medical Devices - Webinar By GlobalCompliancePanel

  April 07, 2011  

GlobalCompliancePanel, Online Training Webinar

Overview: This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

FMEA (Failure Mode & Effects Analysis) is only a segment of Risk Management, but quite valuable for assessing Risk as part of Risk Management. Now that EN 1441 Risk Analysis is obsolete & upgraded to 14971 Medical Devices - Application of Risk Management to Medical Devices, all facets of risk management must be considered from cradle to grave. The term "Risk Analysis" is no longer appropriate for medical device manufacturers and has been replaced by "Risk Management".

Areas Covered in the Session:
  • Failure Mode Analysis Terms
  • Risk Management and FDA
  • Risk Management in Design Control
  • Risk Management & ISO 14971
  • Risk Management in Design Control
  • Risk Management & ISO 14971
  • Risk Management & Medical Device Directives
Who Will Benefit:
  • Regulatory Professionals
  • Quality Engineers
  • Manufacturing Engineers
  • Operations Executives
  • QA Managers
Organized by: GlobalCompliancePanel
Invited Speakers: John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.
Deadline for Abstracts: 2011-05-03
Registration: Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
E-mail: webinars@GlobalCompliancePanel.com
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.