Karen Zink McCullough is principal consultant at MM/ Associates, a consulting firm focusing on Quality System development and pharmaceutical microbiology. Ms McCullough is nationally and internationally known for her work in the Bacterial Endotoxins Test (BET), and is a frequent speaker, instructor author on such topics as BET, GMP, Metrics, Risk, and pharmaceutical microbiology. Her credits include editing two books on Microbiology and BET, authoring 26 book chapters and 19 published articles. She is an elected member of the USP Expert Committee, Microbiology General Chapters and is a US delegate to ISO TC209, Working Group 2, "Biocontamination". Ms. McCullough received her BA degree in Bacteriology from Rutgers University and her MS in Molecular Biology from the University of Oregon.