Calibration in the FDA Regulated Industry Training Course :

The regulations covering manufacture and control of drug products and medical devices require that firms have a program for the calibration of test and measurement equipment. A requirement for calibration is also defined in ISO 9000 and a Quality System for a calibration laboratory is described in ISO 17025. Calibration is a good business and science practice followed in all industries that require measurements for process monitoring and control. The program must include the elements of: calibration intervals, scheduling, specific calibration procedures, limits of accuracy and precision and remedial action in the event that the instrument does not meet established requirements.<br><br> This course addresses the regulatory and business requirements for calibration as an element of a Quality System and how these requirements support the increasing application of process monitoring and sophisticated laboratory instrumentation, along with the maturing discipline of calibration in the regulated industries. It includes a discussion of a compliant calibration program and concludes with a discussion of a model calibration procedure.