Marla K. Stevens-Riley, PhD U.S. FDA

Dr. Stevens-Riley is currently a master microbiology reviewer and Quality Assessment Lead (acting) in the Division of Microbiology Assessment in the Office of Process and Facilities, within the Office of Pharmaceutical Quality (OPQ). Previously, she was a senior microbiology reviewer in the Office of Policy for Pharmaceutical Quality. Prior to the formation of the OPQ, she was a Team Leader in the Division of Microbiology in the Office of Pharmaceutical Science, and a Team Leader and senior microbiology reviewer in the Office of Generic Drugs. She is a Center for Drug Evaluation Research (CDER) liaison to the United States Pharmacopeia General Chapters- Microbiology Expert Committee, and a co-leader on the Parenteral Drug Association (PDA) Task Force responsible for the revision of PDA Technical Report 27: Pharmaceutical Package Integrity.  She was lead author on the Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes. Her recently published papers include, Parametric Release: A Regulatory Perspective (American Pharmaceutical Review), and Regulatory Pathways for Parametric Release (BioPharm Asia). During her scientific career, she has co-authored over 15 peer-reviewed scientific publications. Dr. Stevens-Riley holds a B.S. in Biology from the College of William and Mary, and a Ph.D. in Microbiology from the University of Georgia. She completed her post-doctoral training in the Department of Microbiology and Immunology at the University of Texas Southwestern Medical Center in Dallas.