Objectives of the Presentation
The attendee should understand the need for a comprehensive recovery plan before a cyber attack occurs.
Fundamental cybersecurity program concepts will be identified so attendees have to customize them for their particular needs and implement a program that includes training needs, which is something that can be verified during an FDA inspection.
A firm's quality audit division will be provided some initial issues that need to be considered to develop their QA cybersecurity program and how to evaluate adequacy of the programs based on specific factors.
Why Should you Attend
Cyber attacks constantly evolve in their impact and deviousness of deployment. The FDA expects you to apply the Quality System regulation (QSR) Corrective and Preventive Action (CAPA) as an established and implemented cybersecurity recovery program. This webinar provides initial guidance on how to build a cybersecurity recovery program that includes FDA CAPA elements. The training will address how to prepare a firm's staff for cybersecurity problems. Remember, people carry the biggest "open door" for a hacker. You can use FDA's optional follow-up options. Finally, you can take away a basic checklist that a cybersecurity audit team should include in their program. It is a start from which you can further develop and refine a cybersecurity program as you gain experience.
Who will Benefit
- Initial steps to build a cybersecurity recovery program
- Basic components of a cybersecurity CAPA Program
- Human resources requirements
- Cyber attack recovery components
- Cybersecurity program checklist
- Software engineers, developers and information technology managers
- Third party software servicers
- In-house biomedical departments at healthcare institutions
- Regulatory Affairs Managers
- Healthcare institution risk managers
- Product liability counsel
- Complaint investigation teams
- Quality assurance directors
Software cybersecurity programs keep a firm vulnerable to devastating outcomes that have a severe impact on the firm and the users of software. The FBI identifies the medical device industry and the FDA as the last prepared sector of industry and government to manage this problem. Heath care products and treatment management remains incredibly vulnerable. If fact, you may carrying an infective malware program in your iPhone, laptop or in a remote printer or photocopier. Nothing is safe, not even the federal government.