Boosting DSCSA Regulatory Preparedness for FDA’s Drug Supply Chain Security Act Compliance with Copilot Integrated Generative AI/ML
Conference Theater 2
Track 5: Regional Insights
Information
- Why DSCSA was created by US Congress, some history of past undertakings
- Who’s who and what’s what with DSCSA trading partner roles for drug manufacturers, repackagers, wholesale distributors, 3rd party logistics & service providers, dispensers Challenges for regulatory compliance with DSCSA from various FDA DSCSA pilot project participants including key findings from FDA’s Final report assessment on participant pilot reports submitted to FDA
- Why many remain unprepared-search gauntlet with US FDA.Gov website abysmal metadata searching specific to DSCSA vs Google browser search inherent web noise or clutter when seeking DSCSA relevant context-specific information
- Illustrate new AI/ML Microsoft Copilot & chatbot platform/ technology with underlying AI/ML generative technology via ChatpGPT-4 LLM under the hood
- Extending Copilot with your custom enterprise external data and leveraging cloud-based Microsoft Sharepoint Online Full-Text search on actual US FDA collections hosted within Sharepoint Online to fact-check generative response accuracy by You-the-Human
