This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
GAMP was established by industry leaders to interpret and improve the understanding of regulations governing the use of computerized systems in pharmaceutical manufacturing.
Immediately apply the course learning objectives with pre and post assessments, complementary downloadable guidance document GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems Guide, 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.
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.
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