ASQ Raleigh Life Sciences Special Interest Group Meeting--November 19, 2025

This event is free and open to the public. No ASQ membership is required. ASQ members will receive RU credits for attending.

Title: Unlocking Efficiency, Consistency, and Insight: Potential Use Cases for Artificial Intelligence in Quality Assurance

Abstract:

As regulated manufacturing operations embrace modern digital tools and advanced analytics, Quality Assurance (QA) faces mounting pressure to manage greater complexity and faster decision cycles. Artificial intelligence (AI) offers powerful tools to meet these challenges by enhancing efficiency, consistency, and insight across the quality landscape.

This collaborative discussion explores practical use cases where AI tools can be deployed to deliver value in QA. By connecting these applications under the broader framework of Quality 4.0, this session will illustrate how AI can shift QA from a reactive, compliance-focused role to a proactive, data-informed partner in manufacturing excellence.

Attendees will have the opportunity to share how AI tools may be gaining traction within their own QA organizations to provide real-world examples that may resonate with the entire group.

Presenter: Nathan Blazei, ASQ-CQA, RAC-US, Senior Director, Strategic Solutions at Kymanox

Bio:

Nathan is a versatile life sciences professional with nearly 25 years of experience across biopharmaceuticals, medical devices, and combination products in individual contributor and leadership roles. He has experience working for start-ups and global manufacturers, as well as in professional services/consulting. He is passionate about commercializing safe and effective products that will improve the quality of life for patients and their caregivers.

Nathan's career foundation began in engineering, product and process development, manufacturing, continuous improvement, and program management roles. Over time, he made a transition to focus on quality and regulatory compliance to complement his technical experience. At the intersection of these disciplines is where he has found success over the years, as he can provide solutions that are not only technically sound, but also compliant with evolving regulatory requirements and at the leading edge of industry best practices.

Nathan acquired the Certified Quality Auditor (CQA) designation through the American Society for Quality (ASQ) and hold a Regulatory Affairs Certification (RAC-US) through the Regulatory Affairs Professionals Society (RAPS). Additionally, he is currently a Board Member for the Parenteral Drug Association (PDA), Southeast Chapter. Nathan has presented at domestic and international industry events on various topics relevant to the life sciences to share best practices, lessons learned, and new approaches to solving problems.

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