Simone E. Pitts MS U.S. FDA

Simone Pitts is a National Expert Pharmaceutical Investigator in FDA’s Office of Regulatory Affairs. Her +25 years of regulatory experience at FDA spans working as a Microbiologist, Investigator, Foreign Drug Cadre Investigator, and Team Biologics Investigator to her current position as a National Expert. Ms. Pitts is a global Subject Matter Expert in Biologics, Pharmaceutical, and API inspections; and a global industry thought leader in inspectional areas including Aseptic Manufacturing Operations, Process Validation, and Cross-Contamination Control Strategy. Over the course of her career, Ms. Pitts developed specialized expertise to conduct and direct highly technical, complex, multi-faceted and in-depth domestic and international inspections and investigations of active pharmaceutical ingredients and finished drug products with extensive experience in areas including but not limited to large and small volume parenterals, vaccines, allergenic extract products, antivenins, plasma derived products (and their recombinant analogues), licensed IVD products, gene/cellular therapy products and human cells, tissues and cellular and tissue based products. She holds a BS in Biology and a MS degree in Microbiology, while also serving as a training resource for FDA.