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This course, the first in a four-part series, describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used on the manufacture of pharmaceuticals, biologicals, and medical devices. It does not cover the detailed requirements of 21 CFR Part 11, except for the requirement that systems be validated. Even though it draws upon medical device guidance, it is not intended to cover all the requirements of producing software that subsequently becomes part of a medical device.
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: $ 99.00 Non Member Price: $ 149.00 Item #: WEBTREDU1US
An engaging three-day event you won't want to miss.