Failure Modes and Effects Analysis - An effective Risk Management Tool

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Failure Modes and Effects Analysis - An effective
Risk Management Tool
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
2
Who can benefit from this webinar

• 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

OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
3
Webinar Description
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has been replaced by "Risk Management".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is now a withdrawn standard and ISO
149712000Medical 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 134852003.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
4
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
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
5
Objectives of the Webinar

• FMEA FMECA
• Risk Management vs.ISO 134852003
• Risk Management ISO 14971
• FDAs Risk Management Requirements
• Design Control Risk Management
• Medical Device Directives Risk Management

OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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Instructor Profile
John Chapman Medical Device Consultant
John Chapman, BS, MBA, RAC has over 30 years
medical device regulatory experience and over 10
years experience with the European Unions
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.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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About OnlineCompliancePanel
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OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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Failure Modes and Effects Analysis - An effective
Risk Management Tool
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OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com