Mary Carver Pharma Microbiology Consulting, LLC

Ms. Carver is a Senior Consultant and founder of Pharma Microbiology Consulting, LLC, where she specializes in pharmaceutical microbiology and aseptic processing. She has over 26 years of experience in the pharmaceutical/medical device industries. Work experience includes microbiology, aseptic processing, quality assurance/quality control, environmental monitoring, validation, sterilization, microscopy, and clinical product development/manufacturing support. She has managed microbiology laboratories for various well known organizations. In her last industry position, she was Associate Director Microbiology for Eisai Inc. in Research Triangle Park, NC, where she was responsible for supporting aseptic manufacturing lines and oral solid dose manufacturing as well as development of clinical drug products. She has started-up of two Microbiology Laboratories, supported validation of two newly constructed isolator lines, and designed and implemented environmental monitoring programs intended to satisfy worldwide regulatory requirements. Over the past five years as a consultant, Ms. Carver has provided training in microbiology and aseptic processing, performed GMP audits, and consulted on sterilization and microbial testing issues. She holds a B.A. in Bacteriology from DePauw University in Greencastle, Indiana. Ms. Carver has been a member of PDA since 1991 and is a former president of the PDA Southeast Chapter.