Failure Modes and Effects Analysis - An effective Risk Management Tool - PowerPoint PPT Presentation

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Failure Modes and Effects Analysis - An effective Risk Management Tool

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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. For more details please contact customersupport@onlinecompliancepanel.com – PowerPoint PPT presentation

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Title: Failure Modes and Effects Analysis - An effective Risk Management Tool


1
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has been replaced by "Risk Management".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is now a withdrawn standard and ISO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
6
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
7
About OnlineCompliancePanel
Online Compliance Panel creates and delivers
comprehensive industry relevant training
sessions. These sessions are simple, interactive
and cost effective. We are a predominantly web
based information exchange forum. Live
interactions on compliance training make the
process holistic and effective. Online Compliance
Panel largely emphasizes in offering regulatory
compliance training to compliance professionals
on varied topics. These primarily include risk
management, quality management, corporate
compliance and other regulatory compliances. Some
of our primary areas of focus include advancement
and updates in regulatory compliance, best
practices and market trends. We strive to
incorporate high standards in developing a
culture facilitating exchange of ideas resulting
in functional excellence. Online Compliance Panel
believes in nurturing ideas and thought processes
through innovative e-learning methodologies. Our
products and services are designed to offer
customized solutions to industry and market. We
bridge the gap between experience and knowledge
thus delivering original and creative
content. Our objectives of employing interactive
mediums ensure effective communication and mutual
exchange of ideas. Online Compliance Panel
closely follows best practices and regulatory
trends in the global compliance scenario. We also
observe and communicate trends witnessed in FDA,
ISO regulations, process and design validation.
All updates and additions to important laws can
be accessed by our customers in real time. Our
mission is to empower compliance professionals
through effective online training sessions. Our
world class training methodologies stem from
comprehensive understanding of client
requirements. The content conforming to FDA and
ISO standards is developed by well qualified and
experienced industry leaders. Our offerings will
exceed expectations and add value to your
investment. The content in various categories
such as medical devices, pharmaceuticals and
biotechnology will raise the bar in terms of
quality already on offer .We hope to contribute
to the creation of responsible organizations
creating benchmarks in quality, integrity and
transparency.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
8
Failure Modes and Effects Analysis - An effective
Risk Management Tool
Register Here http//bit.ly/RiskManagementTool F
or more details please contact customersupport_at_onl
inecompliancepanel.com
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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