Mr. Guardino is currently the founder and principal microbiology consultant for MicroGuard Consulting, LLC, a company that exists to assist the Pharmaceutical and Biotechnology industries with microbiological compliance and concerns. Prior to this role Mr. Guardino served as the Director of the Microbiology Lab 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 before spending 20 years in cGMP industries.
Frank Settineri, with over 30 years of pharmaceutical manufacturing and business experience, is an authority on GMP compliance, deviations and investigations, root cause analysis, rectification of sterile and non-sterile microbiological data deviations, particulate matter, and outsourcing of suppliers, contract laboratories and manufacturing sites. He is particularly adept at writing responses to 483s and warning letters that result in both interim controls and sustained cGMP compliance. He is the principal of Veracorp LLC, whose clients include virtual start-ups, compounding pharmacies, API manufacturers, solid and liquid oral dosage manufacturers, sterile facilities, medical device operations and microbiology laboratories. Veracorp LLC assembles teams of multidisciplinary experts and often leads its client’s quality system remediation initiatives.