Bio

Kym has over 20 years of experience in managing a microbiology laboratory and assuring compliance with governing agencies, client specifications, and developing the quality assurance aspect to conform to current advances in pharmaceutical, medical device, biotechnology and cosmetic industries. She has an extensive background in microbiology, specializing in validation of microbiological methods and compendia testing. Her experience includes compliance with USP, FDA, ISO, EU, AAMI & AOAC requirements, general microbiology testing, Environmental Monitoring data analysis and trending, and microbiology quality assurance programs. Recent certifications include: Certificate from UCSD in Regulatory Affairs, certified manager of quality/organizational excellence, and certified quality auditor from ASQ. Kym also serves on the Controlled Environments Testing Association as a board member, American Society for Microbiology as a Science Educators Network Mentor & Reviewer, and Society for General Microbiology as a reviewer. Kym is a member of Regulatory Affairs Professional Society (RAPS), American Society for Quality (ASQ) -Senior Member, Parenteral Drug Association (PDA), Institute for Validation Technology (IVT) and Bio-pharmaceutical Education and Training Association (BETA). She has several publications and has served as a lecturer & trainer for USP <797> compliance.