/Dr. David  /Limspeaker of compliance global
Speaker: Dr. David Lim

Duration: 60 Minutes
Product Code: 700078
Level: Intermediate

Best Practices for FDA-Compliant Cybersecurity Management for Premarket Submissions of Medical Devices.

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Overview

This webinar is intended to help you get familiar with the FDA-compliant management of medical device cybersecurity for regulatory purposes.

This webinar is further intended to increase our awareness that effective management of cybersecurity can greatly reduce the risk to patients by reducing the likelihood of compromising cybersecurity whether it is intentional or unintentional. 

This webinar will address the best practices for cybersecurity 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 guidance practices.

Why Should You Attend

  • To adequately manage cybersecurity for your medical devices containing software so that patient safety risks can be minimized.

Areas Covered in this Webinar

• Laws and Regulations
• Definition
• Cybersecurity Principles and Functions
• Key Functional Requirements for Cybersecurity
• Regulatory Requirements
• Documentation
• Relevant and Applicable Standards
• Best Practices: Do’s and Don’ts
• PASS-IT Recommendations

Learning Objectives

  • To understand and better manage cybersecurity for your medical devices containing software for premarket submission purposes.

Who Will Benefit

• Regulatory Affairs Professionals
• Healthcare Professionals
• FDA Professionals
• Quality Professionals
• Medical Device Design Professionals
• Medical Device Scientists and Engineers
• R&D Professionals
• Complaint and Risk Management Personnel
• Consultants
• Contractors/Subcontractors
• CEOs
• VPs
• Clinical Affairs Consultants
• Other Interested Parties

Speaker Profile

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k) and PMAs in various forums and meetings. Recently, Dr. Lim developed 510(k) and PMA templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA's transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider at FDA news.

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Product ID:700078
Duration: 60 Minutes

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