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Module 2: Applying the GAMP® 5 Guide – An Overview
Module 3: Applying the GAMP® 5 Guide – Lifecycle Detail
Module 4: GAMP® 5 – User Supplier Activities
Module 5: Quality Risk Management
Module 6: Testing
Module 7: Operational Phase
Module 8: Efficient and Effective Compliance
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. 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: 1.30 ISPE CEUs will be awarded upon successful completion of grading requirements
$ 700.00 / € 540.00
Non Member Price:
$ 800.00 / € 620.00
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