James E. Carter is a Principal in the consulting firm Regulatory
Compliance Initiatives, Inc.(RCI), and has more than 25
years experience in the pharmaceutical industry including over
nine years as a consultant. He specializes in all aspects
of Analytical Development, Quality Assurance (QA) and current Good
Manufacturing Practice (cGMP) regulations. Numerous clients
have utilized his capabilities to institute quality systems and
effectively manage regulatory scrutiny by the FDA.
As a consultant Dr. Carter established Omega Pharmaceutical Consulting,
Inc.and Omega Training & Auditing, Inc. Through
these firms his work has included worldwide audits of active pharmaceutical
ingredient (API) suppliers and dosage form manufacturers. Many companies
have utilized his capabilities to review systems and to prepare for an FDA
preapproval inspection. He has helped clients institute Quality Policies,
governing Standard Operating Procedures (SOPs) and CAPA initiatives.
Dr. Carter has performed training related to cGMPs for QA and the laboratory
and FDA inspections. A total of 14 modules are available to assist companies
in their compliance initiatives.
From 1982 to 1991 Dr. Carter was with Johnson & Johnson (J&J) and
for six of those years was with Janssen, the discovery company within J&J.
While Director of QA & Technical Services at Janssen,
Dr. Carter was responsible for the development and approval of numerous INDs
and NDAs.
Prior to consulting, Dr. Carter was Director of Product Development with Boehringer
Mannheim Pharmaceuticals in Maryland. Because Boehringer was
based in Mannheim, Germany, his job function included a large international
component.
Dr. Carter has a BS degree in Chemistry (1966) and an MS degree in Microbiology
(1969) from Brigham Young University. He received his PhD in Medicinal Chemistry
from the University of Utah in 1975.
