The Center for Professional Advancement, Dublin
24-25 September 2007
Who Should Attend:
This overview course is intended for individuals in all industries, but specifically individuals in FDA regulated industries, who are responsible for establishing, maintaining, operating a calibration program, and audit of calibration activities, including:Quality Assurance
Quality Control
Quality Engineering
Technical Support
Research and Development
Facilities and Equipment Maintenance
Description:
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. 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.
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