THE EFFECTIVENESS OF A NOVEL cGMP REFRESHER TRAINING PROGRAM ON THE AWARENESS OF FEDERAL REGULATIONS IMPACTING BIOMEDICAL RESEARCH

Abstract

Current Good Manufacturing Practices (cGMPs) require that "each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training and experience to enable that person to perform the assigned functions (21 Code of Federal Regulations 211.25(a))." This project seeks to develop an effective training program for the GMPs. Common issues regarding cGMP guidelines were investigated and compiled into a database. A novel computer-based training program in a game show format was developed linking to the question database. This software was tested at Lonza in Walkersville, Maryland and Hood College. Matched pair t-test analysis shows that survey matching scores improved by almost two points on average for all participants and each trainee's self-evaluation of his or her cGMP knowledge increased by almost one point on a ten-point scale. This training delivered an effective and unique way of improving training compliance.