Why Should You Attend:
FMEA is a tool designed for product reliability, which has been modified for use in risk management but has some pitfalls in this use. The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process.
Areas Covered in the Webinar:
Who Will Benefit:
This webinar will inform personnel at medical device companies on how to properly use Failure Modes and Effects Analysis (FEMA) in performing risk management.
Edwin Bills, has over 30 years’ experience in the field of quality and regulatory affairs. During his career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions including a recent period as Corporate Director of Risk Management. Currently he consults and provides training in the area of medical device quality, regulatory and risk management.
Mr. Bills is also a member of the adjunct faculty serving Virginia Tech’s graduate on-line degree program in Health Products Risk Management. ASQ has awarded Mr. Bills with Fellow status as well as Certified Quality Engineer, Certified Quality Auditor, Certified Manager of Quality and Organizational Excellence, and he is a Regulatory Affairs Certified by the Regulatory Affairs Professionals Society.
Mr. Bills has also served in international standards work, participating in the development of ISO 14971 risk management standard and IEC 60601-1 electrical medical device standard. He also serves on the US national committee for the medical devices quality system standard, ISO 13485, which is currently being revised, and the international committee on medical device risk management.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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