Due to the growth of the cybersecurity threat to electronic records, computer-controlled manufacturing, and medical devices, the US FDA has issued Guidances for Industry, e.g.: 1) “Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software Document”, and 2) “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” - just updated again in September 2023, and 3) “Postmarket Management of Cybersecurity in Medical Devices”.
This webinar will focus on the key issues raised by the FDA, not just for devices, but expectations for the industry. Cybersecurity in the medical products industry is coming under increased regulatory review. The Agency leaves the how of cybersecurity compliance up to the manufacturer, as long as the principles in the guidances are met in the resulting product and/or system; and on electronic-specific tools/techniques to achieve CGMP compliance. Updates, upgrades, new revisions/releases, service packs, and similar are automatically uploaded to a company’s systems, which can pose security risks, with the potential for introduction of compromised code, retrieval of confidential data, data integrity issues, and similar; and render previous computer systems’ verification and validations worthless.
The necessary role of the system administrator adds another area of concern. This webinar will consider how cybersecurity is introduced into the CGMPs, design control (21 CFR 820.30) for devices, post-production by the CAPA system, FDA sanctioned - NIST recommendations, among others.
Areas Covered:-
Background:-
Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information. The FDA frequently updates its Guidances on cybersecurity compliance due to its constantly evolving nature.
Why Should You Attend:-
Cybersecurity is preventing the theft/modification of e-records by unauthorized access. A growing concern for all – legal, financial, consumer, personal, and the FDA. It's a recent concern for the medical products industries, a result of their increased reliance on networked electronic software, records, and signatures. Initially, there were regulations such as 21 CFR Part 11 in the U.S. and Annex 11 in Europe. But they are insufficient to prevent this growing threat. The FDA and news media have emphasized the prevalence of cybersecurity issues, such as data/identity theft, and hacking which pose hazards to many activities and businesses/industries.
Cybersecurity is an issue that will only increase over time, as records become more electronic, and communications are more networked or accessible to outsiders/hackers. As a result, the FDA has mandated further requirements to be taken by regulated industries to better control this threat, in validations, CGMP documentation, and submissions to the Agency in what is a constantly evolving field of "catch-up" to hacker specialists and nation-state players.
Who Should Attend:-