AI-Powered Quality and GMP Compliance

Please register online via: https://us06web.zoom.us/webinar/register/WN_qpEuUZgITMyeufxvRrf_ow

Title: AI-Powered Quality and GMP Compliance

Abstract: This session explores how artificial intelligence transforms quality and GMP operations, starting with the foundational enterprise knowledge base built from QMS historical quality event reports, DMS documentation, past audit records and external regulatory frameworks.

In this webinar, we will deep dive into the core use cases of AI for audit management: from proactive pre-audit risk mitigation and AI-generated audit plans, real-time evidence retrieval and compliant response support during on-site inspections, to accelerated regulatory response drafting and evidence packaging post-audit, with a live case sharing of end-to-end AI-augmented audit lifecycle management.

Finally, we will briefly cover additional high-impact AI applications in GMP workflows, including automated regulatory intelligence acquisition, batch record drafting, production intelligent inspection and deviation/CAPA report support, to showcase the full scope of AI-enabled quality operational efficiency and compliance.

Speaker: As Vice President and Head of Global Quality, Dr. Rose Xu leads global product quality for Altruist, providing strategic oversight of quality systems, manufacturing quality, regulatory inspection readiness, and commercialization to ensure compliance with global regulatory standards and support the successful delivery of high-quality medicines to patients worldwide.

Prior to her role at Altruist, Dr. Xu joined Innovent Biologics as Vice President and Head of Global Product Quality in December 2025. She brings nearly 20 years of experience at the U.S. FDA, including five years in medical device review and 15 years in regulatory review of drug products, with expertise in Chemistry, Manufacturing, and Controls (CMC) as well as facility compliance. Throughout her FDA career, she conducted and supported numerous domestic and international inspections and regulatory assessments, contributing to the approval and lifecycle oversight of both small molecule and biologics products. She also played a key role in developing FDA internal policies and regulatory guidance documents.

Before joining the FDA, Dr. Xu gained 10 years of industry experience in pharmaceutical research and development, providing her with a strong understanding of product development across the entire lifecycle. She holds a bachelor’s degree from Fudan University School of Medicine, a master’s degree from Arizona State University, and pursued her Ph.D. studies at Johns Hopkins University School of Medicine.