Failure Modes and Effects Analysis - An effective Risk Management Tool
Duration: 60 Minutes
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 The term "Risk Analysis" is no longer appropriate for medical device manufacturers and has been replaced by "Risk Management".
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Download AgendaEN 1441 is now a withdrawn standard and ISO 14971:2000 Medical Devices -- Application of Risk Management to Medical Devices has been the harmonized standard for risk assessment of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. 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.
Why Should you Attend:
Getting through a regulatory audit and how to prepare for it, is vital for companies to know and often helps determine the direction of the audit. Preparation is key as well as knowing what inspectors will focus on and actions to avoid. This webinar will give attendees a template to use to help devise a training program to those responsible for meeting inspectors, the audit team, those who will deal with inspectors as well as upper management. Finally, after getting through an audit, observations made still need to be responded to and this webinar will give suggestions as to how best to address them.
Objectives of the Presentation:
Objectives of the presentation are to cover areas such as:
- 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
Companies interested in understanding and implementing a quality management system that is universally accepted by regulatory authorities. Employees who will benefit include:
- Quality & Regulatory Professionals
- Quality System Auditors
- Manufacturing & Design Engineers
- Marketing Product Managers
How it works
Live Session - How it works
- Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
- The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
- Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
- Login to the audio conference on the scheduled date and time
- Get answers to your queries through interactive Q&A sessions via chat at the end of the session
- Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
- Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
- Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
- Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
- Please click on the link to access the Recorded Session
- Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
- Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
- Please share your valuable Feedback at the end of the session
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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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.
View More