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.
The 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.
This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.
ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.
Approximate Course Duration: 2 Days (this is a self-paced course)
*NOTE* You will have 14 calendar days to access and complete this course from time of purchase.
ISPE CEUs: 1.20 ISPE CEUs will be awarded upon successful completion of grading requirements