FDA Remediation: Preparation, Response and Execution

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• FDA Remediation Preparation, Response and
  Execution

FDA Remediation
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2

• Instructor Profile
• David Amor is a medical device
  consultant, having worked with companies such as
  Boston Scientific, St. Jude Medical and Hospira
  in helping develop quality management systems and
  product development infrastructures. A graduate
  of the Senior Innovation Fellows program at the
  University of Minnesota Medical Device Center,
  David was named a Top 40 Under 40 Medical Device
  Innovator in 2012 and founded MEDgineering. David
  has a strong technical background, having
  garnered his BS and MS in Biomedical Engineering
  from the University of Miami with a focus on
  innovating around clinical needs.
• He is a published speaker, participating
  in most major medical device trade shows,
  including presentations at MDM East and MDM
  West, the two largest medical device conferences
  in the world, where he lectures on topics
  centering on innovative compliance practices.

www.onlinecompliancepanel.com 510-857-5896
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• Description
• FDA actions, 483s or warning letters
  are scary propositions - unless you know how to
  assess and manage them. This course will walk
  students through reacting to FDA actions or
  requests including assessing, planning,
  responding and follow-up. Learn through case
  studies and actual warning letter examples on
  what to do and what not to do before, during and
  after an inspection.

www.onlinecompliancepanel.com 510-857-5896
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• Why Should you Attend?
• Attend this webinar and learn more
  about FDA Remediation Preparation, Response and
  Execution because all companies will go through
  FDA remediation at some point. 
• Objectives of the Presentation
• Objectives of the presentation are to
• discuss about FDA remediation and Quality System.
• Who can Benefit?
• Medical device professionals.

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• 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
• Get certification of attendance.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• 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
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• Get Connected With Us

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