Join FDA and Industry Experts to Develop Quality, Regulatory, and Supply Chain Solutions Through the Power of AI

AI Realized. The Xavier Artificial Intelligence Initiative presents AI Summit 2018, August 23-24. Be a part of the future of our industry by:

  • Understanding the current use of AI in the medical device and pharma industries
  • Exploring cutting-edge possibilities of how the power of AI can be applied to solve your challenges in quality, regulatory, and supply chain
  • Engaging in AI industry-wide solution discussion sessions
  • Joining an AI Solution Team during the summit and beyond
  • Shaping the future of our industry…now

Register now for the AI Summit 2018, happening August 23-24.

AI could help improve our oversight and accelerate bringing products to market. It has the potential to fill in the gaps that we can not see or get to in our current approach/paradigm.
— Cisco Vicenty, Program Manager – Case for Quality, CDRH, FDA

Featured Speakers 2017


Who Should Attend

  • Medical Device professionals
  • Pharmaceutical professionals
  • Quality operations, regulatory affairs and supply chain professionals
  • AI experts
  • AI end users
  • Those who are interested in AI applications, but are not versed in AI
  • Small, medium and large organizations
  • Global regulators

What Can We Do Together?

Here are just a few examples:

This is it. This is the future of Quality.
— Art O. Czabaniuk, Program Division Director/District Director, Office of Regulatory Affairs, Division of Pharmaceutical Quality Operations III, FDA
  1. Continuous Audit System: Develop an expert process to audit all of your documents constantly, instead of conducting an annual audit on 2% of your documents.  Start by interviewing expert auditors and investigators to identify their “if/then” thought process on how they conduct audits.  Move from “audit findings” to predicting areas of failure.
  2. Predicting Product Failure: Fold in as much data and variables as you can surrounding your production process to identify sources of influence on your product quality that weren’t previously realized (think of incoming variables, facility, human, time of year, supply base, stock prices, every specification range, etc.). Work together to identify which common and uncommon variables could be included.
  3. True Root Cause: Identify triggers in your investigations and CAPA documents that could signal deeper root causes and trends that have not been recognized, then develop a consistent process for root cause identification across your organization. Output could include a standard list of root causes and related failures for industry use.
  4. Robust Supplier Selection and Monitoring: Develop a process to scan external information related to suppliers during the due diligence process – prior to signing a contract. Then continue monitoring external information on your supplier’s performance with other clients that could impact your products. Identify what types of information and sources to scan.

What If My Company is Small or Has Not Started With AI?

  • All of the examples above can benefit every company, since each example can be implemented by humans.  The output of our work will identify successful practices from industry-wide experts that can be used by humans in all organizations. The next step would be to have those practices augmented through the power of AI.
  • The work we will accomplish together will help some companies understand the criticality of moving beyond paper-based systems to simple electronic systems, let alone implementing AI. Humans cannot reasonably identify trends and assess large amounts of information if the information is contained on paper, thus exposing your patients and company to unidentified risk.
  • If your company is ready to start with AI, the systems can be developed on your own, you can hire consultants, or you can contract with solution providers.  Since all of those examples can be scaled to what you are ready for, the power of AI is within your reach...today.

Agenda Highlights 2017

Actionable insights on these topics and more:

  • Validation - Using AI to Make Decisions?
  • FDA Perspective on the Power of AI
  • Exploring AI Innovation in Quality, Regulatory and Supply Chain

AI Summit 2017 Sponsors

Because of the generosity of our sponsors, we can continue our work to innovate our industry. Thank you!


Experience the Xavier Difference

Your one-of-a-kind experience with us is rooted in our mission of:

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 participants 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 leaders 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 summit armed with action plans that are orchestrated throughout the summit and solidified before you leave.