Summit Workshop:
Putting AI Into Motion Across GxP Organizations

Tuesday, August 20, 2019

Expert leaders will spend the day with you during this hands-on workshop diving into the challenges, opportunities and successful practices of artificial intelligence. Whether you are already using the power of AI in your organization, or just getting started, this workshop will support your ability to advance the impact of your results (e.g. across quality operations, manufacturing operations, supply chain, product development, etc.)! Gain a deeper understanding of how to increase the success of the outcomes, decrease the risk of decisions you make from the algorithms, and increase the confidence you have in relying on the results. Register today for this interactive workshop, Tuesday, August 20, 2019, 8:30am-4:30pm at Xavier University.


  • Donna-Bea Tillman (former FDA): Learn how to navigate the regulatory pathway for AI product approval from Donna-Bea Tillman

  • Ramani Routray (IBM Master Inventor): Understand from Ramani Routray how to train AI in a way that builds trust

  • Toni Manzano (AI Expert): Toni Manzano will demystify AI so you can incorporate the power of AI across your organization

  • Pat Baird (Philips) and Bob Banta (Eli Lilly): Gain insight on how to leverage existing risk models to incorporate AI factors.


Facilitated by Mac McKeen (Boston Scientific Corporation), expert leaders will engage you in an immersive learning experience on the following aspects of Artificial Intelligence:

8:00 AM - 8:30 AM
Join your colleagues from around the globe as we kick off the AI Summit with a complimentary warm breakfast.

8:30 AM - 8:45 AM
Workshop Welcome
Welcome to the Summit and welcome to Xavier University. We look forward to working with you to advance the industry through the power of AI.

8:45 AM - 10:00 AM
Demystifying AI
Explore the differences between AI, machine learning, deep learning, cognitive learning, neural networks, natural language processing, natural language generation, and…the list goes on. A theoretical framework will be explored within a set of real world exercises, highlighting the GxP connotations. Don’t miss this opportunity to unravel the mystery so you can lead innovation across your organization.

Workshop Leader:

  • Toni Manzano, R&D Director, Bigfinite

10:00 AM - 10:15 AM

10:15 AM - 11:30 AM
From Train to Trust
As we branch into innovative spaces, we need to bridge new approaches with existing expectations. Learn and understand the end-to-end training process starting from training data curation to model tuning and validation, how they are performed, and what they mean. We also focus on the process of provenance for the model generation in the AI/ML pipeline to make it reproducible for regulatory audit compliance. Explore the space on how to train algorithms in a way that gains trust through explainability and track the lineage for the model through its lifecycle.

Workshop Leader:

  • Ramani Routray, STSM and Manager, IBM Master Inventor, IBM Watson Health - Life Sciences

11:30 PM - 12:15 PM

12:15 PM - 1:30 PM
AI Risk Management
Through a Total Product Lifecycle (TPLC) approach to risk management, expert facilitators will explore what makes AI/ML software different while working to leverage existing risk management models.  Unique risks to AI/ML software will be assessed, such as locked versus unlocked (adaptive or unsupervised) algorithms, control of data sets (both training and production), which risk-management related design control deliverables are most likely to be impacted by AI/ML device software, and how AI/ML explainability must be integrated into risk management methods to control risks associated with black box solutions. Return to your organization with practical insight on risk management of AI/ML systems across risks, such as: safety, security, privacy, data integrity, fraud, reputation management, product liability, compliance, version control, and data set bias.

Workshop Leaders:

  • Pat Baird, Regulatory Head of Global Software Standards, Philips

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

1:30 PM - 1:45 PM

1:45 PM - 3:00 PM
Regulatory Expectations and Pathways for AI
Understand how traditional expectations of “validation” are impacted by systems that continuously learn, and how this could affect the success of your product approval if not supported with sound methodologies. During this session, you will learn how best to prepare your product filings with data and studies when AI is involved in your product and/or processes.

Workshop Leader:

  • Donna-Bea Tillman, Group Leader, Medical Devices, Biologics Consulting

3:00 PM - 3:15 PM

3:15 PM - 4:30 PM
AI Adoption Across Your Organization
Successful practices will be shared on how to gain adoption for the use of AI within your organization, the cultural changes needed, training on how to make decisions responsibly from the output, how to demonstrate to your organization the value of AI, while also providing realistic cost analysis and return on investment.

Workshop Leader:

  • Steve Frigon, Senior Clinical Systems Analyst, The Christ Hospital

Participants will have an opportunity to dive into the Xavier AI Working Team publications to support their learning and next steps.

Expert Facilitators

Who Should Attend?

  • Quality, Regulatory, Operations, R&D, Clinical Trials and Supply Chain functions

  • Bring your data scientists and cross-functional peers! You will be able to better influence the advancement of your organization if your data scientist and cross-functional peers understand the vision, and together you understand the technical realities. No problem if you do not have a data scientist in your organization.

  • Regulators

  • Any life science industry

  • Companies of all sizes

  • Consultants and service providers to the life science industries


Join us at Xavier University on Tuesday, August 20, 2019, from 8:30am-4:00pm for the “Putting AI Into Motion Across GxP Organizations” Workshop. The cost of this immersive experience is $850, but plan on extending your stay to join FDA and your industry colleagues for the entire Xavier AI Summit (the workshop is August 20, main summit sessions are August 21-22). For complete information on planning your visit with us, click here.