Stephanie Calhoun Email and Phone Number

Seven + years of QA / compliance experience. Managed quality and compliance for a third-party logistics provider (3PL) handling prescription drug samples, OTC drugs, medical devices and cold-chain products. Current role is at the corporate level in the radiopharmaceutical manufacturing space. Extensive GMP (210, 211, 212, 820) and PDMA knowledge. Seasoned auditor / auditee with FDA, DEA and NABP inspection experience. Dual Drug and Medical Device Certificate from RAPS. Previous experiences in aseptic technique, training and pharma preclinical compliance.