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.
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?
- 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.
- 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.
- 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.
- 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
- Full agenda