Failure Modes and Effects Analysis - An effective Risk Management Tool

1

• Failure Modes and Effects Analysis - An effective
  Risk Management Tool

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
2

• Instructor Profile
• 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.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
3

• 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  has been replaced by "Risk Management.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  is now a withdrawn standard and ISO 149712000
  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 134852003. 

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
4

• 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_at_onlinecompliancepanel.com
5

• Objectives of the Presentation
• Objectives of the presentation are to
  cover areas such as
• FMEA FMECA
• Risk Management vs.ISO 134852003
• 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_at_onlinecompliancepanel.com
6

• 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_at_onlinecompliancepanel.com
7

• 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
  QA 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_at_onlinecompliancepanel.com
8

• Get Connected With Us

www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com