About Our Consultants

Consultants-Dr. Tony Cundell

Dr. Tony Cundell

Dr. Cundell consults in the pharmaceutical industry in the areas of microbial risk assessment, regulatory affairs, and microbiological testing. Prior to November 2013 he worked for Merck Research Laboratories in Summit, New Jersey, as a Senior Principal Scientist in early phase drug development. Earlier in his career, Tony Cundell worked at a director level in Quality Control and Product Development organizations at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough.

 

He is a member of the 2015-2020 U.S.P. Microbiology Committee of Experts where he takes a leadership role in the area of modern microbiology methods. 

 

Tony Cundell has a Ph.D. in Microbiology from the Lincoln University, New Zealand.

Bob has over 30 years of experience in GMP industries, including Quality Control Microbiology, Quality Assurance and Regulatory Affairs.  He has worked for biotechnology and pharmaceutical manufacturers, as well as for pharmaceutical, biotechnology, cosmetic, and food contract testing laboratories.  He has played key roles in numerous U.S. and international regulatory inspections.  He holds a Master of Science degree from Temple University in Quality Assurance / Regulatory Affairs.  He is Regulatory Affairs Certified (RAC) and is a Certified Manager of Quality / Organizational Excellence (CMQ / OE).  He is a member of the Pharmaceutical Microbiology Forum (PMF), the American Society for Microbiology (ASM), the Parenteral Drug Association (PDA), the Regulatory Affairs Professional Society (RAPS), and a Senior Member of the American Society for Quality (ASQ).

Consultants-Bob Guardino

Bob 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 as 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.  His Quality System / Good Manufacturing Practice Regulations experience spans 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. 

Mr. Guardino's consulting work with Pharmaceutical Quality Standards will not include work with the recreational cannabis industry, medical cannabis only.

Consultants-Bob Westney

Bob Westney

Consultants-Bob Guardino

Bob 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 as 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.  His Quality System / Good Manufacturing Practice Regulations experience spans 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. 

Mr. Guardino's consulting work with Pharmaceutical Quality Standards will not include work with the recreational cannabis industry, medical cannabis only.

Consultants-Bob Westney

Bob Westney

Consultants-Steve Lane

Steven has 30 years of development, manufacturing, and laboratory experience in the pharmaceutical industry including 9 years at the United States Pharmacopeia where he oversaw 6 global laboratories.  While at USP, he oversaw the development of the first compendial cannabinoid methods and standards that were published for the approved drug dronabinol.  USP also maintained (at the request of DEA) analytical chemistry standards for all schedules of drugs as well as precursors.  Lane holds a BS from East Tennessee State University where he studied Chemistry and Microbiology, a MS from Johns Hopkins University where he studied Biotechnology, and is currently pursuing a second Master’s Degree from Harvard University in Biomedical Engineering.
 

Steve Lane