The Microbiology Network provides a range of microbiology consultants and trainers for your needs. All microbiology consultants are experienced in industrial microbiology and contamination control, with particular emphasis in the pharmaceutical industry, personal care products industries, medical devices or compounding pharmacy. Areas of expertise range from laboratory operations, corporate GMP and Quality, and regulatory submissions / response to 483 and warning letters.
Search for a consultant by the following Topics of Interest. You may select more than one.
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.
Bob Westney is currently President and Director of Quality and Operations for Cryologics Inc., which specializes in formulating in-house microbial isolates into the format required for compendial tests. He is also Principal Consultant for Westney & Associates Consulting LLC. Bob has 25 years of experience in the GMP industry, including Quality Control Microbiology, Quality Assurance and Regulatory Affairs. He has worked for biotechnology and pharmaceutical manufacturers, as well as pharmaceutical, cosmetic, and food contract testing laboratories.
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. Mestrandrea has more than thirty five years of QA/QC experience in the Pharmaceutical Industry. He was the Senior Science Advisor for Pfizer’s Global Quality Technical Services Group; the Director Worldwide Microbiology Support at Schering-Plough; Associate Director of QA at Sandoz and the Chief Microbiologist at the Brooklyn District Office of the FDA. He also has more than 25 years experience as an Adjunct Professor teaching at a number of universities and colleges in the New York and New Jersey areas and is a member of the USP Microbiology and Sterility Assurance Expert Committee. He holds a Doctorate in Microbiology from St. John’s University/Pacific Western University, a Master of Science degree in Clinical Microbiology from Wagner College and a Bachelor of Science degree from St. John’s University.
For over 25 years, Tony has managed several contract laboratory organizations to regulatory and financial success. Mr. Grilli has advised hundreds of clients on matters of regulatory compliance, technical method validation, and microbial remediation. He has hosted and conducted audits, authored protocols, designed laboratories, developed laboratory quality systems, remediated 483 observations, and developed Lean Sigma laboratory processes. He has published in peer reviewed journals and has presented at seminars. He is active in several organizations, including President of New Jersey Society of Industrial Microbiology, Parenteral Drug Administration, Personal Care Product Council, and American Society of Quality.