GMP operations occasionally require external consulting expertise to develop or confirm compliant solutions.
API® consulting and training division specializes in contamination control, cleaning and disinfection, disinfectant validation, component entry, environmental monitoring, aseptic processing, gowning, media fills, CIP/COP, and personnel training.
Our expertise includes but is not limited to faculty members at PDA TRI since its inception, routine CBER/CDER/EMEA/MHRA training since 2001, Faculty USP 797 training, assistance to FDA in writing sections of the Aseptic Processing Guide, countless book chapters, industry papers, industry presentations and consulting projects for nearly 40 years.