Microbiological Method Validation and Testing of Sterile and Nonsterile Pharmaceutical Products from Drug Development to Product Release and Post-Market Surveillance

Mr. Guardino is the managing partner and principal microbiology consultant for MicroGuard Consulting, LLC, a company that exists to assist the Pharmaceutical and Biotechnology industries, and Compounding Pharmacies with microbiological compliance and concerns. In this role, Mr. Guardino has served as an international consultant on four continents over the past seven years. Prior to this role, Mr. Guardino served as the Director of Microbiology for AAIPharma Services Corp. where he oversaw a full-service contract Microbiology Laboratory in support of the Pharmaceutical and Biotechnology industries. In this role, Mr. Guardino interacted with many clients and client companies offering consulting and testing services. After earning a Master of Science Degree from the University of Buffalo in Medical Technology with a concentration in Microbiology, he performed research in Microbiology and Biotechnology for several years. Mr. Guardino has also held positions as a product development / quality assurance supervisor for rapid microbial diagnostic products and as a principal scientist during the development of PCR-based diagnostic products for a JNJ Company. His Quality System / Good Manufacturing Practice Regulations experience span over 30 years. Areas of expertise include microbial contamination and control; microbial specifications for non-sterile and sterile dosage forms; drug substance, excipient, in-process and finished product microbiological method suitability and testing requirements; release and stability requirements and testing; sterility assurance and aseptic processing, down-stream / purification process contamination and control strategies for biotechnology products; disinfectant qualification; water system and environmental validation; and compounding pharmacy regulations and microbiology-related requirements. He has presented seminars and workshops domestically and internationally on theory of microbiology testing, including training for FDA CDER and CBER branches.