Simone Pitts MS U.S. FDA

Simone Pitts MS

Simone Pitts MS U.S. FDA National Expert, Pharmaceutical, ORA

Simone Pitts is a National Expert, Pharmaceutical, in FDA’s Office of Regulatory Affairs. Her +20 years of regulatory experience at FDA spans working as a Microbiologist, Domestic Investigator, Foreign Drug Cadre Investigator, and Team Biologics Investigator to her current position as a National Expert, Pharmaceutical. Ms. Pitts is recognized as a global Subject Matter Expert in Biologics, Pharmaceutical, and Active Pharmaceutical Ingredients (API) inspections; and a global industry thought leader in inspectional areas including Process Validation and Data Integrity. 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 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 bachelor’s degree in Biology and a master’s degree in Microbiology. Ms. Pitts also serves as a training resource for FDA.