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: 40 pm

Cybersecurity Summit Roadmap: Brief Review of Day One and Outline of the Day Ahead

Speaker:

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

8:40 AM - 10:00 AM

The Quality Management System Adapted for Cybersecurity

Tailoring your Quality Management System to respond to cybersecurity threats is vital to effective risk management.  A case study will be used to explore key points to integrate cybersecurity risk management practices into your Quality Management System governance and procedures 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.

Moderator:

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

Speakers

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

10:00 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.

Moderator:

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

Speakers: 

  • Bob Banta, Consultant – Global Device Quality Assurance, Eli Lilly
  • Fubin Wu, Co-Founder and President, GessNet

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 you need to make to your complaint management process; who you have to notify if you experience a data breach (customers and regulators); and how to pick an information sharing analysis organization to exchange/share cybersecurity vulnerabilities.

This session will continue after lunch.

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

12:30 PM - 1:30 PM

Lunch


1:30 pM - 3:00 PM

Managing Post-Market Cybersecurity Risk (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

This session will continue after the break.


3:00 PM - 3:20 PM

Break


3:20 PM - 4:50 PM

Managing Post-Market Cybersecurity Risk (continued)

Moderator:

  • Fubin Wu, Co-Founder and President, GessNet

Speakers:

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

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.

Speaker: 

  • Michelle Rich, Associate Director of Program Development, Xavier Health