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.
Agenda
- 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 Should Attend
- 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
