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The recently revised EU GMP Annex 11 and Chapter 4 (which have been adopted for international use by PIC/S) are also covered. As well as the European and international expectations for electronic records and signatures, the general requirements for computer systems validation and compliance as described in Annex 11 will be explained in detail. This self-paced, pre-recorded course includes a downable 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.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. Immediately apply the course learning objectives with pre and post assessments, downloadable course presentation for note taking, learning reviews highlighting important points, hot-links to regulatory and industry information, and an online resource handout as a quick reference for all web links discussed. ISPE CEUs: 1.20 ISPE CEUs will be awarded upon successful completion of grading requirements
$ 400.00 / € 365.00
Non Member Price:
$ 500.00 / € 440.00