Software Cybersecurity – Prevention and Recovery
Duration : 1 Hours
Casper (Cap) Uldriks, Former Associate Center Director of FDA's CDRH
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radi Read more
FDA conducts establishment inspections to determine a firm’s conformance applicable regulatory requirements. Inspections provide a degree of assurance that the manufactured products will conform to their specifications to support the concept of it being “safe and effective.” Inspections vary on the type of product you make and are prioritized on the risk to health associated with your product. FDA presumes you know what you are doing but checks just to be sure. Inspections need not provoke anxiety if you have properly prepared, but all too often firms fail to realize that inspections need not break into high drama.
Course Objectives:
• Understand FDA’s Software Design Cybersecurity Requirements
• Differentiate what events are reportable to FDA
• Identify voluntary standards that FDA uses for cybersecurity assessment
• Outline cybersecurity raining concerns
• Explain the basic steps for cybersecurity attack recovery
Why Should You Attend:
There is no secret about what an investigator looks for. If you do not, you will likely receive a list of observations that provide concrete examples of nonconformance. At the end of the inspection firms wonder, “So, how bad was it?” You can estimate the gravity of your situation using a few simple guides that FDA uses for the same question. Learn how to handle yourself and FDA during and after the inspection. FDA expects to clean up your problems and prevent them from happening again. Inspectional findings, noted on a Form FDA 483, show you the truth of your noncompliance in FDA’s eyes. You bear the consequences, which can be severe. Now, you can learn about some basic tools that most people do not even know exist. Hence, there are no big surprises and you can relax.
Course Outline:
• FDA’s Premarket Cybersecurity Design Information
• FDA’s Postmarket Controls and Reporting Options
• Voluntary Controls
• Cybersecurity Training
• Recovery Plans
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Business Planning Executives
• Regulatory Directors
• Software design and specification developers
• Software Architecture System Developers
• Real time software performance auditors
• Recall managers
• In-house Legal Counsel
• Customer support and service directors
• Contract Specialists
• Business acquisition Managers
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
Similar Trainings
Write it Right – Well Written Procedures are Essential for QMS Effectiveness
LIVE : Scheduled on
17-January-2025 :01:00 PM EST
|
FDA Audit Best Practices - Dos and Don'ts
LIVE : Scheduled on
24-January-2025 :01:00 PM EST
|
