Barbara Randolph, RQAP(GLP), BS, MBA, MT(ASCP)

Senior Auditor/Owner

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Barbara has worked in the regulated research industry as a quality assurance professional for over 27 years. During her career she has assessed procedures and processes; developed written SOPs, data collection forms, and quality management system policies; audited vendors and CROs; inspected laboratories, toxicology facilities, clinical investigator sites conducting GLP- and GCP-regulated studies, and clinical monitoring and database CROs; performed mock regulatory inspections for sponsors and CROs; and audited all types of data and reports. She provides quality assurance and quality review services for research discovery studies, safety studies, animal clinical trials, bioanalytical method validations and analyses, and human clinical trials. She also has experience monitoring sites for veterinary clinical trials.  Barbara has presented a wide range of topics in training sessions at national meetings of the Society of Quality Assurance (SQA) and the American College of Toxicology (ACT). She has served in various offices for the Pacific Regional Chapter of SQA and has been elected to the SQA Education Committee and the Council on Professional Registration.  She has volunteered on the RQAP(GLP) Exam Committee for over 10 years.  Additionally, Barbara has developed and presented customized GLP and GCP training for clients conducting research in various fields. Prior to her QA professional career, she worked as a certified/licensed clinical laboratory technologist in immunohematology, hematology, cytogenetics, radioimmunoassay, and chemistry laboratories. Barbara holds an MBA and an undergraduate degree in genetics and is both a registered quality assurance professional (RQAP-GLP) and a certified medical technologist (MT(ASCP)).

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Sherry Fowler, RQAP(GLP), BS, MS

Senior Auditor/Owner

 

Sherry is a QA professional with eight years of experience in regulated quality assurance and acquired her professional registration in Good Laboratory Practice (RQAP-GLP) in 2013.  She performs GLP and GCP quality review and quality control compliance evaluations and audits of data and reports in areas such as: bioanalytical, method validation, bioequivalence, biosimilar, toxicology, pathology and veterinary.  She has also conducted GLP inspections of laboratories, study phase audits and GLP archive audits, developed audit and data sampling plans, and created data collection forms.  Sherry obtained her Master of Science in Biology degree with extensive field and laboratory research in plant physiological, ecological, and botanical studies.  She brings experience in dairy farming, as a college biological laboratory instructor, and as a science teacher in Secondary Education, where Sherry instructed individual/student research projects, Advanced Placement Biology, Ecology and Microbiology.  Sherry is a published researcher with scientific articles in peer-reviewed biological/environmental journals such as the American Midland Naturalist.

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            for a partial list of Presentations, Posters, and Publications