Bio

Occupation:Independent Consultant, Biopharmaceutical and Regulatory Sciences Industry

College: College of Agriculture and Life Sciences ’81

Affiliations: NSF Health Advisory Board; Society of Toxicologic Pathology and the Society of Quality Assurance. She has served on scientific and regulatory policy initiatives within the Society of Toxicologic Pathology and has acted as a liaison between the two organizations for many years. She regularly participates in national scientific and quality assurance meetings and has presented on topics related to GLP compliance, regulatory expectations, and quality systems. Dr. Lanning also volunteers with North Carolina State University Alumni Association programs, including more than two decades of service supporting the Caldwell Fellows Program through application review and finalist interviews.

Lynda Lanning, D.V.M., DABT is an independent consultant specializing in toxicologic pathology, risk assessment, Good Laboratory Practice (GLP) compliance and regulatory toxicology, with more than 35 years of experience spanning government, industry and contract research organizations. Prior to retiring from the U.S. Food and Drug Administration in 2023, where she served within the Center for Drug Evaluation and Research (CDER), Office of Study Integrity and Surveillance, she focused on GLP compliance and inspectional oversight for regulatory submissions.

Lanning currently provides strategic guidance to sponsors, CROs and government programs in areas including nonclinical safety assessment, study oversight, inspection readiness, quality systems and regulatory submissions supporting investigational new drugs, new drug applications, biologics license applications and Animal Rule programs.

Lanning is recognized for her expertise in data integrity, quality process improvement and the interpretation of nonclinical pathology findings in support of regulatory decision-making. She has been an active contributor to professional organizations including the Society of Toxicologic Pathology and the Society of Quality Assurance, where she has participated in scientific and regulatory policy initiatives and served as a speaker at national meetings. Lanning’s work is distinguished by a practical, science-based approach that bridges regulatory expectations with operational execution.