Cybersecurity and US FDA Requirements

Why Should You Attend:

Cybersecurity is the 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.

There are 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. The US also has the Health Insurance Portability and Accountability Act of 1996 (HIPAA) requirements for patient data protections. The EU has the new, tough General Data Protection Regulation (GDPR), as of May 2018.

So, 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, submissions to the Agency.

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”, and 3) “Post market Management of Cybersecurity in Medical Devices” -- Draft.

This webinar will focus on the key issues raised by the FDA, not just for devices, but expectations for industry. Cybersecurity in the medical products industries 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, and post-production by the CAPA system, among others.

Areas Covered in the Webinar:

• Cybersecurity and the FDA
• Key Guidance Documents on Cybersecurity
• FDA’s enforcement approaches
• Network vulnerabilities issues
• Cloud, updates and other concerns
• FDA’s regulatory approach; Examples
• Design, security tools and other requirements
• Validation and unique documentation requirements

Who Will Benefit:

• Senior management in Devices, Combination Products
• QA / RA
• Software development, programming, documentation, testing teams
• R&D
• Engineering
• Production
• Operations
• Marketing
• Consultants; others tasked with product, process, electronic records software V&V responsibilities