Title: Preparing for Quality Audits in the AI Era
Subtitle: From Regulatory to Surveillance “So What?”
Speaker: George Kwiecinski
- Opening Slide – The New Reality
- Why This Topic Matters Now
- From Data-Rich to Insight-Poor (Revisited)
- What Will Auditors Ask in the AI Era
- Top 5 Audit Risks with AI Systems
- AI vs. GMP Principles – Where They Clash
- Rethinking Validation for AI
- The Human Factor Still Matters
- Using AI the Right Way for Audit Readiness
- Audit Preparation vs. Continuous Readiness (AI Edition)
- Practical Framework for Organizations
- Case Study
- Key Takeaways
Brief Summary
AI is changing how regulators assess quality systems, shifting audits from documentation to decision-making and control. Organizations must manage risks such as data integrity, model validation, and overreliance on automation.
The key message AI does not replace GMP, it requires stronger oversight, lifecycle control, and continuous audit readiness.
Brief Bio – George Kwiecinski
George Kwiecinski is an entrepreneur, engineer, and Founder & CEO of Global Key Solutions, a company that leverages regulatory data and AI to improve audit readiness and compliance in the life sciences industry.
He has a strong background in engineering and bioengineering, with a focus on applying data analytics and technology to pharmaceutical quality systems. His work centers on translating FDA inspection trends, warning letters, and compliance data into actionable insights for industry professionals.
Kwiecinski is actively involved in the biotech and regulatory community, contributing to innovation in quality systems and promoting smarter, data-driven approaches to compliance and audit preparation.