Biography
Dr. James C. Norris has a Ph.D. in Pharmacology and Toxicology, as well as a M.S. and B.S., in Chemistry. His certifications include: Diplomate of the American Board of Toxicology (D.A.B.T.) and the European Register of Toxicology (ERT). He is an Associate Professor at Harding University in the College of Pharmacy within the Pharmaceutical Sciences Department, where he lectures to the Pharm D and Physician Assistant students on Pathophysiology and Pharmacology. He also serves as a consultant for biotechnology companies, medical university researchers, Chinese CROs, private equity companies, and industrial projects. In the past, he has served as an industrial representative, an on-site industrial crisis management member, a testimonial witness to United States Consumer Product Safety Commission, and a presenter to the United States EPA National Advisory Committee.
He conducted GLP studies and managed GLP facilities for over 15 years. While General Manager at a Charles River facility, the three US FDA inspections resulted in no 483’s. During these years, he actively participated in numerous sponsor QA inspections and QA qualifying reviews in the US, England and China. Additionally, he advised a Chinese CRO in obtaining AAALAC certification as a mentor to senior management and Chinese technical staff and as a facility reviewer. He provided guidance to the Chinese CRO on management processes and business development. He assisted in preparation for the SFDA inspection. He also conducted QA inspections at another Chinese CRO on SOPs, training records, technician work processes, and facility reviews, as well as conducted training seminars for senior and technician staff. He prepared this Chinese CRO for an AAALAC inspection which was very successful.
He also serves as an expert witness in pharmacology and toxicology for reports, depositions and trial testimonies (Civil, Criminal, and Military courts; Plaintiff and Defense)
in the United States, Hong Kong, and the United Kingdom.
Research Interest
His interest: general pharmacology and toxicology, inhalation, neuropharmacology/toxicology and blood coagulation.