ISPE CEUs: 1.3
Type: Classroom Training Course
This course is also available as an online training course, Basic Principles of Computerized Systems Compliance course.
This course has been updated to include the new revised EU GMP Annex 11, and an overview of 21 CFR Part 11.
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.
The course does not aim to cover detailed and highly technical aspects of software and hardware engineering, but rather gives the principles and an overview of the overall computer systems compliance process, including a scaleable and efficient system lifecycle, Quality Risk Management applying ICH Q9, updated GAMP categories, supplier assessment, and the selection of appropriate specification and verification activities.
Immediately apply the course learning objectives using the complimentary copy of the GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems Guide.
This course was developed by members of the ISPE GAMP Community of Practice. GAMP was established by industry leaders to interpret and improve the understanding of regulations governing the use of computerized systems in pharmaceutical manufacturing.
This training course is of particular interest to existing and future members of the ISPE GAMP Community of Practice (COP).