Failure Modes and Effects Analysis - An effective Risk Management Tool

Date	Oct 7, 2014
Time	12:00 PM EDT
Cost	$235.00
Online

FMEA (Failure Mode Effects Analysis) has long been recognized as a valuable tool in risk assessment and should be considered as an integral part of risk management. FMEA has been used as part of Risk Analysis under the obsolete standard EN 1441 - Risk Analysis for Medical Devices. The term "Risk Analysis" is no longer appropriate for medical device manufacturers and has been replaced by "Risk Management". EN 1441 is now a withdrawn standard and ISO 14971:2000Medical Devices -- Application of Risk Management to Medical Devices has been the harmonized standard for risk assessment of medical devices under the medical devices directives and referred to in ISO 13485:2003.
Why Should you Attend:
This presentation will acquaint one with 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.

Objectives of the Presentation:
To know more on

• FMEA & FMECA
• Risk Management vs.ISO 13485:2003
• Risk Management & ISO 14971
• FDA’s Risk Management Requirements
• Design Control Risk Management
• Medical Device Directives & Risk Management

Who can Benefit:

• Companies interested in understanding and implementing a quality management system that is universally accepted by regulatory authorities.
• Quality & Regulatory Professionals
• Quality System Auditors
• Manufacturing & Design Engineers
• Marketing Product Managers

Live Session - How it works

• Username and Password will be sent to you 24 hours prior to the webinar
• Presentation handouts in pdf formate will be mailed to you
• Login to the session using the username and password provided to you
• Get answer to your queries through interactive Q&A sessions via chat
• Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
• Get certification of attendance.

Recorded Session - How it works

• A link will be provided to you upon purchase of the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf formate will be mailed to you
• Get certification of attendance.

Instructor Profile:

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 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 2004Fundamentals 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.

John has had specialized training and experience in FDA QSR, ISO 13485, European Medical Device Directives, ISO 9001, Canadian Medical Device Regulations, Auditing, Root Cause Analysis, Design Control, Bloodborne Pathogens, Hazardous Waste Handling, and FDA regulations. He has also presented live on-line seminars on various regulatory subjects.

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