Implementing FDA - compliant cyber security requirements for premarket submissions of medical devices

1
Implementing FDA - compliant cyber security
requirements for premarket submissions of medical
devices
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• Instructor Profile
• Dr. David Lim is President
  and Principal of Regulatory Doctor. Regulatory
  Doctor provides Practical, Actionable, and
  Sustainable Solutions in an Integrated, Thorough
  ("PASS-IT") manner.Dr. Lim obtained his Ph.D.
  in biological sciences at the University of
  Missouri-Columbia and published his thesis
  research in the prestigious journal "Science."
  Since then, Dr. Lim has held various positions at
  Duke, Caltech, US National Laboratories, Intrexon
  Corporation, Terumo, US FDA/CDRH, and EraGen
  Biosciences, Inc., A Luminex Company. In 2009,
  Dr. Lim served as a panel member during the FDAs
  Transparency Public Meeting. Prior to founding
  his own consulting firm (www.RegulatoryDoctor.com)
  , Dr. Lim was Senior Vice President of Scientific
  and Regulatory Affairs at Aquavit
  Pharmaceuticals, Inc. in New York. Dr. Lim as
  Regulatory Doctor provides practical, actionable
  and strategic solutions integrated with emotional
  intelligence (EQ) skills for all aspects of
  global regulatory, quality, clinical and
  compliance matters.

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• Description
• This webinar is intended
  to help you get familiar with the FDA-compliant
  management of cyber security for regulatory
  purposes. This training session is further
  intended to increase our awareness that effective
  management of cyber security can reduce the risk
  to patients by reducing the likelihood of
  compromising cyber security whether it is
  intentional or unintentional. This webinar will
  address the best practices for cyber security
  management for premarket submission purposes
  concerning medical devices containing software as
  well as software that is a medical device. The
  speaker will walk you through the FDA compliant
  practices.
• Why Should you Attend
• To adequately manage cyber
  security for your medical devices containing
  software so that patient safety risks can be
  minimized. 

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• Objectives of the Presentation
• The objectives of the presentation are to
  teach about
• EU Laws For Medical Devices
• Definition
• Principles
• Cyber security Functions
• Key Functional Requirements for Cyber security
• How to Address the Requirements
• Documentation
• Relevant and Applicable Standards
• Best Practices Do's and Don'ts
• PASS-IT Recommendations

• Who can Benefit
• Regulatory Affairs
• Quality Professionals
• RD
• Complaint And Risk Management Personnel
• Consultants
• Contractors/Subcontractors
• CEOs
• VPs
• Clinical Affairs
• Other Interested Parties

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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 formate 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 formate 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

• www.onlinecompliancepanel.com

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