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This course, the third in a four-part series, has been designed by the International Society for Pharmaceutical Engineering (ISPE) and UL EduNeering, in cooperation with the Food and Drug Administration (FDA)/Office of Regulatory Affairs ORA, to assist FDA personnel in recognizing the critical aspects of computerized systems in the pharmaceutical industry during Pre-Approval and routine current Good Manufacturing Practices cGMP inspections. The course explains how computerized systems are used in the pharmaceutical manufacturing process and provides an approach to inspecting these systems.
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: 60 minutes (this is a self-paced course)*NOTE* You will have 5 calendar days to access and complete this course from time of purchase.ISPE CEUs: .10 ISPE CEUs will be awarded upon successful completion of grading requirements
Member Price: $ 79.00 Non Member Price: $ 149.00 Item #: WEBTREDU3US
An engaging three-day event you won't want to miss.