Calibration is an essential element in ensuring compliance in the pharmaceutical and associated regulated life science industries. To ensure success, calibration should be managed effectively, by appropriately qualified and competent personnel. This online course provides guidance in setting up a calibration management system, which will give a structured approach to instrument risk assessment, calibration program management, documentation, and corrective actions, essential to regulatory compliance. This online course will describe a system of calibration management, which defines what needs to be done, when, by whom, and why, as well as identify regulatory requirements and business benefits. This course is designed to provide broad fundamental industry knowledge through a customized learning experience for individuals that want to expand their knowledge of GAMP5. The course includes pre and post assessments, downloadable course presentation for note taking, learning reviews highlighting important points, hot-links to regulatory and industry information, and online resource handouts as appropriate for quick reference. Immediately apply the course learning objectives with an electronic download of the ISPE GPG: Calibration Management, 2nd Ed.
This training course is of particular interest to existing and future members of the ISPE GAMP Community of Practice (COP).