Cybersecurity Summit 2017 Agenda
Day 1: Tuesday, October 24


8:00 AM - 8:30 AM

Breakfast

Join your colleagues for a 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.

Speakers: 

  • Seth Carmody, Cybersecurity Program Manager, FDA – CDRH
  • Michelle Rich, Associate Director of Program Development, Xavier Health

8:45 AM - 9:30 AM

Device Cybersecurity: Taking a Multidisciplinary Approach

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.

Moderator:

  • Bob Banta, Consultant – Global Device Quality Assurance, Eli Lilly

Speakers: 

  • Bob Banta
  • Seth Carmody, Cybersecurity Program Manager, FDA – CDRH

9:30 AM - 10:20 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.

Moderator:

  • Rick Chapman, Sr. Director, Regulatory Affairs, CMC – Combination Products and Medical Devices, Biogen

Speakers: 

  • Rick Chapman
  • Michelle Jump, Principal Regulatory Affairs Specialist, Stryker

10:20 AM - 10:40 AM

Break


10:40 AM - 11:10 AM

Cyber-Vigilance: How to Identify Your Cybersecurity Blind Spots (continued)

Speakers: 

  • Rick Chapman, Sr. Director, Regulatory Affairs, CMC – Combination Products and Medical Devices, Biogen
  • Michelle Jump, Principal Regulatory Affairs Specialist, Stryker

11:10 AM - 12:10 PM

Developing and Implementing a Pre-Market Cybersecurity System

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 continued after lunch.

Moderator:

  • Fubin Wu, Co-Founder and President, GessNet

Speakers: 

  • Fubin Wu

12:10 PM - 1:00 PM

Lunch


1:00 PM - 2:45 PM

Developing and Implementing a Pre-Market Cybersecurity System (continued)

Final segment to this session will continue after a short break.

Moderator:

  • Fubin Wu, Co-Founder and President, GessNet

Speakers: 

  • Fubin Wu

2:45 PM - 3:05 PM

Break


3:05 PM - 4:25 PM

Developing and Implementing a Pre-Market Cybersecurity System (continued)

Moderator:

  • Fubin Wu, Co-Founder and President, GessNet

Speakers: 

  • Bob Banta, Consultant – Global Device Quality Assurance, Eli Lilly
  • Seth Carmody, Cybersecurity Program Manager, FDA – CDRH
  • Fubin Wu

4:25 PM - 5:00 PM

Protecting the Patient Protects You

Gain insight into the FTC’s point of view where building Cybersecurity into the design of a product is imperative in protecting the patient from harm and you from possible liability.

Moderator:

  • Jon Steiger, Regional Director, Federal Trade Commission

Speakers: 

  • Jon Steiger

5:00 PM - 7:00 PM

Networking Reception

After the summit sessions, benefit from open dialog while enjoying drinks and hors d’oeuvres. You and your colleagues can continue to share ideas with the Cybersecurity Core Team and each other in a pleasant, informal setting.