FMEA and Risk Management for Medical Devices

Date:Thursday, June 09, 2011
Time:10:00 AM PDT | 01:00 PM EDT
Live Webinar
Duration:60 Minutes
FMEA and Risk Management for Medical
Devices
Price:$245.00

Overview: This presentation will explain the various terms


Register Now
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.
InstructorProfile:

John Chapman
FMEA (Failure Mode & Effects Analysis) is only a segment of
Regulatory Affairs
Risk Management, but quite valuable for assessing Risk as
Professional
part of Risk Management. Now that EN 1441 Risk Analysis is
John Chapman, BS, MBA, RAC has
obsolete & upgraded to 14971 Medical Devices - Application of
over 30 years medical device
Risk Management to Medical Devices, all facets of risk
regulatory experience and over 10
management must be considered from cradle to grave. The
years experience with the European
term "Risk Analysis" is no longer appropriate for medical
Union's medical device directive,
device manufacturers and has been replaced by "Risk
93/42/EEC. John has led two device

Management".
companies to ISO quality system

certification and CE marking. He has
Areas Covered in the Session:
been performed regulatory due
diligence on over a dozen
l
Failure Mode Analysis Terms
acquisitions in the past 12 years,
l
Risk Management and FDA
exposing him to numerous quality
l
Risk Management in Design Control
systems, including consent decrees
l
Risk Management & ISO 14971
as well as many notified bodies.
l
Risk Management in Design Control
...more
l
Risk Management & ISO 14971
RelatedProducts
l
Risk Management & Medical Device Directives
ISO 13485 Gap Analysis Toolkit
Click here to register for this webinar
ISO 13485 Quality Manual


Who Will Benefit:
Intro to ISO 13485 Presentation
Materials
l
Regulatory Professionals
ISO 13485 Internal Auditor Checklist
l
Quality Engineers
more...
l
Manufacturing Engineers
l
Operations Executives
Your Necessity is our Priority
l
QA Managers

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit
from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
Best regards,
Event-coordinator
GlobalCompliancePanel
About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for
online compliance training by creating a single window of learning opportunities for compliance professionals &
providing a forum for expert speakers/panelists to render their services through simplified online training delivery
mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices &
quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a
wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded
stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online
environment and also support your E-learning and development on/through our website. Keep track of all webinars
arranged for your industry through notifications & event calendars being mailed to your inbox.
GlobalCompliancePanel opens new doors of learning opportunities for professionals.
GlobalCompliancePanel
www.globalcompliancepanel.com
1000 N West Street Suite,
1200 Wilmington DE 19801

Phone: 800-447-9407 or
Fax your PO to: 302-288-6884
If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

---

---