Cybersecurity Summit Program & Agenda

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Inspiring Collaboration…

•Feel the Purpose-Driven nature of this Summit as soon as you enter the room.
•Expect orchestrated engagement with your peers across the industry on topics you are passionate about.
•Find attendees openly sharing their expertise to help advance the industry in collaboration with regulators.
•Work side-by-side with regulators to deepen the understanding on both sides of challenges and opportunities.

Leading Innovation…
•Identify solutions that will protect your patients around the world, your company brand, and your business.
•Talk about the “elephant in the room” to get to the real pain that plagues our industry.
•Learn what you didn’t know you didn’t know!  Walk away with real solutions.
•Hear directly from speakers who passionately challenge the status quo.

Making a Difference…
•Work through real working models that can improve the reliability of your product…today.
•Learn how you can be part of the solution.
•Understand who your stakeholders are so you can implement meaningful and sustainable change.
•Leave the conference armed with action plans that are orchestrated throughout the Summit and solidified before you leave.

October 24, 2017

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Time Description
8:00 AM - 8:30 AM

Join us for Breakfast at Xavier University!

Join your colleagues for a nice complimentary warm breakfast in the Xavier University Cintas Center to jump start your day!

8:30 AM - 8:45 AM

Let’s Make a Difference

The FDA and Xavier University welcome you to the first annual Xavier Cybersecurity Summit.

8:45 AM - 9:30 AM

Device Cybersecurity: Taking a Multidisciplinary Approach

Integration of multidisciplinary perspectives on your device and combination product will allow you to holistically address cybersecurity challenges across the total product lifecycle.  Explore how cybersecurity is related to patient safety and business risk, how to perform an effective cybersecurity risk analysis, and how to integrate cybersecurity in your risk management process.

9:30 AM - 10:30 AM

Cyber-Vigilance. How to Identify Your Cybersecurity Blind Spots.

A case study approach using several product examples will be used to explore blind spots you may have in your cybersecurity systems.  Walk away with an understanding of:  the risks of open networks versus closed networks; evolving regulations in the United States and Outside the United States; how new technologies may challenge your cybersecurity system effectiveness; the impact of cybersecurity considerations on your business.

 

(This session will be continued after the break)

10:30 AM - 10:50 AM

Break

10:50 AM - 11:20 AM

Cyber-Vigilance. How to Identify Your Cybersecurity Blind Spots

Continuation from prior to break.

11:20 AM - 12:20 PM

Developing and Implementing a Pre-Market Cybersecurity Plan

Dive into a Case Study to understand how to identify threats and vulnerabilities associated with product assets. Walk away with strategy for pre-market risk management actions in accordance with ISO 14971 principles as you explore submission requirements and the inclusion of formative and summative Human Factors studies to support the success of your cybersecurity plan.

 

(This session will be continue after lunch)

12:20 PM - 1:20 PM

Lunch

1:20 PM - 3:20 PM

Developing and Implementing a Pre-Market Cybersecurity Plan

Continuation from prior to lunch.

(Final segment to this session will continue after break)

3:20 PM - 3:40 PM

Break

3:40 PM - 4:40 PM

Developing and Implementing a Pre-Market Cybersecurity Plan

Continuation from prior to break.

4:40 PM - 5:00 PM

Wrap Up

Thank you for joining us, but we insist that you leave with action plans that will enable you to make a difference in your organization and for the patients you serve. Work with your colleagues on turning your learning into a full action plans.

Speakers:

5:00 PM - 7:00 PM

Networking Reception

DAfter the summit sessions , benefit from open dialog while enjoying drinks and hors d’oeuvres. You and your colleagues can continue to share ideas and explore issues with Discussion Leaders in a pleasant, informal setting.

October 25, 2017

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Time Description
8:00 AM - 8:30 AM

Join us for Breakfast at Xavier University!

Join your colleagues for a nice complimentary warm breakfast in the Xavier University Cintas Center to jump start your day!

8:30 AM - 10:00 AM

The Quality Management System Adapted for Cybersecurity

Cybersecurity systems can either strengthen or undermine your Quality Management System.  A case study will be used to explore key points of integration of cybersecurity practices with your existing Quality Management System, including supply chain selections, auditing (internally and externally), CAPA, records management…..and even how to create and manage an Approved Supplier List for cybersecurity-related vendors.

10:00 AM - 10:20 AM

Break

10:20 AM - 11:20 AM

Building Security into Device Software Development Lifecycle Practices

Adopting a “Security by Design” approach for your software development lifecycle will help ensure the success of your cybersecurity plan.  Using a case study, both IEC 62304 and the IEEE Building Code for Medical Device Software Security will provide guidance for “Security by Design” coding practices.

11:20 AM - 12:30 PM

Managing Post-market Cybersecurity Risk

Cybersecurity contingency planning is critical for post-launch success.  Using a Case Study, understand holistically, how cybersecurity risk management is executed after product launch.  What changes do you need to make to your complaint management process; who do you have to notify if you experience a data breach (think about customers and regulators); and how do you pick an Information Sharing Analysis Organization to exchange/share cybersecurity vulnerabilities?

(this session will continue after lunch)

12:30 PM - 1:30 PM

Lunch

1:30 PM - 3:00 PM

Managing Post-Market Cybersecurity Risk

Continuation from prior to LUNCH

 

(this session will continue after BREAK)

3:00 PM - 3:20 PM

Break

3:20 PM - 4:50 PM

Managing Post-Market Cybersecurity Risk

Continuation from prior to break.

4:50 PM - 5:00 PM

To Your Success

Thank you for joining us, but we insist that you leave with action plans that will enable you to make a difference in your organization and for the patients you serve. Work with your colleagues on turning your learning into a full action plans.

Speakers: