FDA expects firms to develop and implement a cybersecurity management program to reduce the impact of malware intrusion. That poses a big challenge because cybersecurity technology constantly evolves into more sophisticated methods, devastating malware packages, and increased stealth in avoiding detection and identification. If your cybersecurity program is relatively static, it turns your software design into a sitting duck. Vigilance plays a key role in cybersecurity management. FDA requires software developers to address cybersecurity issues before and after the software-based devices are marketed. This is part of the FDA’s Total Product Life Cycle paradigm coupled with an effective Corrective and Preventive Action (CAPA) program. However, the FDA provides little guidance on how to manage recovery from failed cybersecurity operations. What should your cybersecurity include? FDA is relying more and more on the use of voluntary standards developed from a number of sources and expects you to do the same.

Areas Covered:-

• Understand the need for an effective and up-to-date cybersecurity program
• Identify the fundamental cybersecurity management concepts 
• Identification of key voluntary standards and the role of the National Institute of Standards and Technology (NIST)
• Identify training needs for employees
• Providing key points of an effective cybersecurity management program.
• Initial steps to building a cybersecurity preventive program
• Basic components of a cybersecurity CAPA program
• Human resources requirements 
• Cyberattack recovery components
• Cybersecurity program checklist

Who Will Benefit?

• Device Manufacturers
• Software engineers
• Design specification developers for hardware/software devices
• Information technology managers and administrators
• Software Forensic Engineers
• Regulatory Affairs Managers
• Quality Assurance Managers
• Regulatory Program and Procedures Developers