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** Permanently Retired Due to Lack of Enrollment **
This course has been designed to assist FDA inspectors in recognizing the critical aspects of computerized systems in the medical device industry. This course explains how computerized systems are used in the medical device manufacturing process and provides an approach to inspecting these systems. This course does not cover the detailed review of software that forms part of a medical device; it covers only inspection of systems that automate part of the device production process or part of the quality system. Before taking this course, users should complete Requirements for Computerized Systems Validation and Compliance and Approach to Computerized Systems Validation and Compliance.
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 #: WEBTREDU4US
An engaging three-day event you won't want to miss.