Regulatory Management 2020 - Learn the Latest FDA’s Regulatory Management of Your Cybersecurity Threats

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,
FDA requires software developers to address cybersecurity issues before and after the software-based devices are marketed. This is part of FDA’s Total Product Life Cycle paradigm coupled with an effective Corrective and Preventive Action (CAPA) program.
Initial steps to building a cybersecurity preventive program
Basic components of a cybersecurity CAPA program
Speaker:
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He conducted domestic and foreign inspections.