Cybersecurity vulnerabilities introduce a new category of risk to our patients, company business and healthcare system as a whole. More and more traditional drug manufacturers are entering drug delivery combination products. The advancement of digital health draws many drug delivery combination products into the connected healthcare ecosystem. As such, cybersecurity has become an important part of the risk management program for drug delivery combination product manufacturers.
In responding to public and governmental concerns, FDA has been increasing focus on cybersecurity. Multiple FDA cybersecurity guidance documents have been released within recent years in expecting manufacturers to address cybersecurity in pre-market submissions as well as post market management throughout product life cycle.
Many existing safety risk management principals and processes can be applied and leveraged for cybersecurity risk management. However, cybersecurity risk management does require a new set of disciplines and skills that manufacturers may not be familiar with or experienced in.
This training course explains cybersecurity risk management principles with comparison to safety risk management. Attendees will walk through methods and associated tools to identify, assess and control cybersecurity risks using drug delivery combination product examples. Best practices on how to properly document cybersecurity for effectiveness and regulatory compliance, as well as key cybersecurity related industry standards, technical reports, and FDA guidance will also be discussed.
The training course provides lecture slides, examples, drug delivery combination product case studies and interactive group exercises for participants to apply their new knowledge and hear feedback from both the trainer and FDA. Participants will also have the opportunity to interact with FDA on questions related to drug delivery combination product cybersecurity.