Failure Modes and Effects Analysis - An effective Risk Management Tool
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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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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 The term "Risk Analysis" is no longer appropriate for medical device manufacturers and has been replaced by "Risk Management“. EN 1441 is now a withdrawn standard and ISO 14971:2000 Medical Devices -- Application of Risk Management to Medical Devices has been the harmonized standard for risk assessment of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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit: 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
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Live Session - How it works? Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf format 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 format will be mailed to you Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com