THE EFFECTIVENESS OF A NOVEL cGMP REFRESHER TRAINING PROGRAM ON THE AWARENESS OF FEDERAL REGULATIONS IMPACTING BIOMEDICAL RESEARCH
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Date
2011-01
Type of Work
Department
Hood College Biology
Program
Biomedical and Environmental Science
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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.