AI in Quality: Practical Applications, Regulatory Perspectives, and Preparing QA Teams
AI is already shaping how life sciences organizations run quality operations. The question isn’t whether to adopt it — it’s how to do so responsibly, defensibly, and in a way regulators will recognize.
In this webinar, Yijia Li (QA Manager, Blue Mountain) and Lori Bleau (Product Solutions Director, Blue Mountain) walk through where AI is delivering real value in QA today, what the FDA is signaling through recent guidance and its own internal AI use, and how to build a program that holds up under inspection.
You’ll learn:
- Practical QA use cases where AI is moving the needle — deviation and CAPA trending, adverse event detection, document and audit readiness, and supplier and inspection support
- What the FDA’s January 2025 draft guidance and its seven-step credibility assessment framework mean for validating AI in a GxP context, plus how FDA is using its own internal LLM (ELSA) to accelerate reviews and inspections
- How emerging standards like ISPE GAMP Annex 22 are reshaping expectations around model validation, data quality, human oversight, and explainability
- How to build the governance, skills, and risk-based processes needed to pilot and scale AI in a value-driven, inspection-ready way
Whether you’re evaluating AI for the first time, running early pilots, or aligning an existing quality strategy with evolving regulatory expectations, this session offers grounded, QA-specific guidance to help you move forward with confidence.