Find Your Consultant
Robert Guardino
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. In this role Mr. Guardino has gained significant experience in microbial contamination and control issues for positron emission tomography (PET) drugs, as well s PET drug GMPs. 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 and supervised an industrial microbiology lab for five 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 20 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 testing requirements; release and stability requirements and testing; down-stream / purification process contamination and control for biotechnology products; disinfectant qualification; water system and environmental validation. He has presented seminars and workshops domestically and internationally on theory of microbiology testing, including training for FDA CDER and CBER branches.
Frank Settineri
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.
Dr. Dave Porter
Dr. Porter has a Ph.D. in Zoology from the University of California at Berkeley. His research involved the use of an in vitro superfusion system of his design using pituitaries in search of mechanisms of action of GnRH, the results of which were presented in twelve publications. This was followed by postdoctoral work in molecular biology at the Ohio State University, and in protein chemistry at Case Western Reserve University.
He has been a consultant in various modes for a number of years. Some of this work has involved helping companies and their teams to understand the why’s of quality system compliances as well as the how’s. It is his belief that when people understand why compliance requirements are written the way they are, compliance with those requirements follows along naturally. He teaches that it is science that dictates what should be done, and that one should always feel free to ask questions rather than just blindly follow SOPs. His clients have included small start-up analytical laboratories, contract manufacturers, major domestic and international companies, law firms (expert witness functions), and the government (BARDA and NASA).
