- OVERVIEW AND WHY SHOULD YOU ATTEND
- AREAS COVERED AND LEARNING OBJECTIVES
- WHO WILL BENEFIT
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.
• Laws and Regulations
• Cybersecurity Principles and Functions
• Key Functional Requirements for Cybersecurity
• Regulatory Requirements
• Relevant and Applicable Standards
• Best Practices: Do’s and Don’ts
• PASS-IT Recommendations
- 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
• Clinical Affairs Consultants
• Other Interested Parties
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.View all trainings by this speaker
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Thank you for the spreadsheet webinar. The webinar was informative and helpful. Although many of the concepts are known and understood by Industrial and Process Engineers, it is always helpful to have a straightforward review. The spreadsheet will be beneficial in being able to help identify areas of risk and areas that may require some attention.
Benchmark Electronics , ******** Engineer
This was a very informative session, it did help my company by raising awareness in areas we lack policies. The only thing I would suggest get added to the session is direct information relating to Accounting, ex. Taxation rules for record retention as they are some records which a company is required to keep indefinitely.
First MCO, ***** Manager
Overall I found the video conference well organized and very informative. The presenter, Ronald Adler, was certainly extremely knowledgeable and presented the subject matter in a well organized, direct and succinct manner. Afford the attendee the ability to track and record paid attendance/activity without a lot of tracking and follow up in order to gather the necessary information required to record the CPEs earned and paid for.
Dynamic Marketing Systems, VP Finance & Human Resources
As this was our first experience, we did not know what to expect. I believe the webinar was informative and to the point, and explained to us the purpose of the I-9, and how the company can be affected by an audit. It really motivated us to review our files and bring them up to date.
Young Transportation, ****Coach****
I have participated in several webinars hosted by Compliance Global on various H&S topics. They are always precise, technologically-oriented, and easy to use and partake in to further my knowledge of current Health and Safety regulations and topics.