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FDA Regulation of Software Cybersecurity and CAPA
• What to build into a cybersecurity program
• How to manage cybersecurity events
• How to recover from an exploitation
• Ways to reduce the likelihood of a cyber attack
• Provide a basic cybersecurity audit check list for corporate use
Overview of the webinar
Cybersecurity has become a critical risk for the medical device industry. The FBI has warned the device industry and the FDA that it is not prepared for managing this problem. FDA lacks the expertise to add any insightful or technical guidance on cybersecurity. FDA will rely on third party sources, such as voluntary standards and the National Institute Standards and Technology (NIST) to give you some sort of direction. Everyone is finding their way, but no one has found a clear path to get ahead of the cyber threat curve. FDA plans to work harder, but in the end, it is up to you.
Who should attend?
• Regulatory affairs directors
• Quality assurance directors
• Quality Control directors
• Corporate business plan managers
• Recall and corrective action managers
Why should you attend?
The webinar will cover the critical elements of FDA’s regulation of software cybersecurity. Building a cybersecurity program before an exploitation occurs should reduce the impact. Corrective and preventive actions will receive more scrutiny and better coordination between inspection, revised premarket programs and the use of voluntary standards. The use of the Total Product Life Cycle (TPLC) incorporates the requirements of CAPA. Looking beyond FDA, device firms need to establish their own cybersecurity program for cybersecurity recovery, which includes managing employees and the public.
Faculty - Mr.Casper Uldriks
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.