Overview:
This webinar covers how FMEAs are usually misused in medical devices, how to get most value from them. It aims at eliminating design defects, manufacturing defects, maintenance mistakes, and designing the device more human-centered so the device can conform to human needs instead the other way.
Why should you Attend:
Companies have not realized the real potentials of FMEA a proactive defect and failure prevention tool. Each element in the life cycle requires a separate FMEA, such as:
Design FMEA
Software FMEA
Electrical System FMEA
Mechanical System FMEA
FMEA for Eliminating Maintenance
FMEA for preventing repair errors
FMEA for Safety Analysis
Process FMEA
FMEA for Packaging, Shipping, Handling, and Storage
Areas Covered in the Session:
Fundamentals of a robust FMEA
Pitfalls to avoid when conducting the FMEA
How to get users involved in the FMEA
How to conduct FMEAs quickly, and efficiently,
Requirements for good team management
Prioritizing risks
How to develop elegant solutions to mitigate risks
How to integrate FMEA in the risk management process
Eliminating design defects to reduce the risks of recall
Eliminating manufacturing defects to the reduce risk of recall
Eliminating packaging, shipping, handling, storage, and disposal errors
Eliminating maintenance mistakes
FMEA for design verification and validation
New paradigms for developing devices cheaper, better, and faster
Who Will Benefit:
Senior Management
Entire Engineering Staff
Test Engineering Staff
Regulatory Affairs Professionals
Production Managers and Engineers
Marketing Managers
Service Managers
Project Managers and Engineers
Quality Assurance Staff
Product Safety Staff
Speaker Profile:
Dev Raheja PE, CSP, is a system safety practitioner, consultant and trainer for over 25 years. He is a Fellow and former Vice President of the System Safety Society and received its Scientific Achievement Award and Educator of the Year Award. He is the author of the text Assurance Technologies Principles and Practices: A System, Process and Safety Perspective. He has conducted System Safety training at Johnson Space Center, Kennedy Space Center, Boeing, US Navy, US Army, Lockheed Martin, and at several universities such as UCLA, George Washington University, University of Maryland, and University of Alabama. He served as Adjunct Professor at University of Maryland during 1994-99, where he taught graduate courses on system safety. He is also the member of the G-48 Committee for the Government-Industry standards and is Associate Editor of the Journal of System Safety.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
http://www.compliance4all.com/
Event Link : http://www.compliance4all.com/control/w_product/~product_id=500765LIVE
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