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.
Module 1: Regulations and Regulators
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
Attendance Suggested for:
Sion Wyn is an acknowledged expert in computer system validation and compliance and international regulations in this field. He assissted the FDA with its re-examination of 21 CFR Part 11, and is a member of the team that produced the FDA Guidance on 21 CFT Part 11 Scope and Application. He is the technical content expert for the FDA's ORA Virtual University on-line training modules on computerized systems validation and compliance. He has received the FDA Group Recognition Award for work on Part 11. Wyn is the editor of ISPE's GAMP5 Guide - A Risk-Based Approach to Compliant GxP Compute
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