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Implementing FDA - compliant cyber security requirements for

This webinar will address the best practices for cyber security management for premarket submission purposes concerning medical devices containing software.

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Implementing FDA - compliant cyber security requirements for

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  1. Implementing FDA - compliant cyber security requirements for premarket submissions of medical devices www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  2. 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 FDA’s 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. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  3. 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.  www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  4. 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 • R&D • Complaint And Risk Management Personnel • Consultants • Contractors/Subcontractors • CEOs • VPs • Clinical Affairs • Other Interested Parties www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  5. Live Session - How it works • Username and Password will be sent to you 24 hours prior to the webinar • Presentation handouts in pdfformate 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 pdfformate will be mailed to you • Get certification of attendance. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  6. Get Connected : www.onlinecompliancepanel.com www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

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