This webinar provides initial guidance on how to build a cybersecurity recovery program that includes FDA CAPA elements. The training will address how to prepare a firm's staff for cybersecurity problems. Remember, people carry the biggest "open door" for a hacker. You can use FDA's optional follow-up options. Finally, you can take away a basic checklist that a cybersecurity audit team should include in their program. It is a start from which you can further develop and refine a cybersecurity program as you gain experience.
Why Should You Attend:
Cybersecurity technology and exploitations evolve rapidly. A static cybersecurity program leaves a software program more vulnerable with each passing day as hackers develop new malware adaptations. Cyber attacks constantly evolve in their impact and deviousness of deployment. The FDA expects you to apply the Quality System regulation (QSR) Corrective and Preventive Action (CAPA) as an established and implemented cybersecurity recovery program and also FDA requires that a software developer, whether for a software based device or for standalone software, address cybersecurity before the device may be marketed. But the cybersecurity problems manifest themselves after premarket authorization. FDA provides little guidance on how to manage a cybersecurity recovery program once you are on the market and have been hit.
What should your cybersecurity recovery program include? You are left with an answer of, "You figure it out".
In this webinar Fundamental cybersecurity program concepts will be identified so attendees have to customize them for their particular needs and implement a program that includes training needs, which is something that can be verified during an FDA inspection. A firm's quality audit division will be provided some initial issues that need to be considered to develop their QA cybersecurity program and how to evaluate adequacy of the programs based on specific factors.
Areas Covered in the Webinar:
- Initial steps to build a cybersecurity recovery program
- Basic components of a cybersecurity CAPA Program
- Human resources requirements
- Cyber attack recovery components
- Cybersecurity program checklist
ex-FDA Expert and former Associate Center Director ,
Casper (Cap) Uldriks owns Encore Insight LLC, which provides consulting services on FDA Law. He 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 as 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. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed.
- Software engineers, developers and information technology managers
- Third party software servicers
- In-house biomedical departments at healthcare institutions
- Regulatory Affairs Managers
- Healthcare institution risk managers
- Product liability counsel
- Complaint investigation teams
- Quality assurance directors