From Prompt to Proof: AI for DEA Compliance and GxP Manufacturing Investigations
Complimentary
Learning Level: Intermediate
Time: 1600 - 1700 ET
Session Length: 1 hour
Artificial intelligence (AI) is rapidly transitioning from concept to implementation across the regulated life sciences industry. Yet, while interest in AI has surged, real-world examples of validated, compliant, and regulator-facing deployments remain rare. This webinar brings together two pioneering case studies that demonstrate how AI can be responsibly implemented within Good Manufacturing Practice (GMP) and U.S. Drug Enforcement Administration (DEA)–regulated environments—showing that innovation and compliance are not mutually exclusive.
In the first presentation, John Clapham, CEO of PSC Biotech and BioTechnique, will explore how BioTechnique leveraged ChatGPT, Claude, and AWS AI services to meet and demonstrate DEA registration compliance. Working in partnership with PSC Software, BioTechnique transformed its regulatory documentation process into an intelligent digital compliance ecosystem. AI was used to author and manage standard operating procedures (SOPs), automate document control workflows, and support audit readiness through PSC Software’s validated ACE enterprise platform. This case highlights how generative AI can be applied under Annex 22 and GMP guidance to create an end-to-end, traceable, and inspection-ready digital environment.
The second presentation, led by Brian Chviruk, Quality Systems Innovation Lead at Takeda Pharmaceuticals, focuses on AI’s role in Quality investigations. Brian will demonstrate how AI-enabled tools, strengthen investigation quality and productivity in a regulated GxP environment. Attendees will see how a “co-pilot, not auto-pilot” approach uses GenAI to draft investigation narratives from human input, surface similar prior deviations to detect recurrence, generate executive summaries, and run an automated “check” against Takeda’s internal standard before QA review. The talk highlights observed benefits—standardization, improved completeness and clarity, time savings, and compliance-by-design.
Together, these presentations provide a grounded look at the evolving intersection of AI, regulatory compliance, and operational excellence. Attendees will gain a deeper understanding of how AI can be deployed within validated systems, how to manage its inherent risks, and how these technologies can strengthen, not replace, human expertise and oversight.
Participants will leave with actionable insights and lessons learned from two organizations that have successfully implemented AI in highly regulated settings and have directly interfaced with regulatory authorities during deployment.
Learning Objectives
- Understand practical strategies for implementing artificial intelligence (AI) within validated, GxP-regulated environments. Participants will learn how AI technologies such as ChatGPT, AWS AI, and advanced analytics can be integrated into existing quality systems to enhance compliance, documentation control, and regulatory readiness.
- Explore real-world case studies demonstrating AI’s role in compliance and manufacturing investigations. Attendees will gain insight into how BioTechnique and Takeda Pharmaceuticals successfully deployed AI to automate DEA documentation, accelerate root cause analysis, and improve data integrity while maintaining alignment with regulatory expectations.
- Identify key considerations for balancing innovation with compliance when interfacing with regulators.The session will highlight lessons learned on validation, data governance, and human–AI collaboration, providing actionable guidance for safely adopting AI solutions in regulated life sciences operations.
