GAMP

Agenda               

This fundamental course introduces participants to regulatory requirements for computerized systems in regulated industries such as medical and pharmaceutical business sectors  and explores 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.

Course Modules

Module 1   : Introduction to GAMP

Module 2   : Regulations and Regulators expectations

Module 3   : Requirements of 21 CFR Part 11

Module 4   : Overview of GAMP 5

Module 5   : GAMP 5 Lifecycle 

Module 6   : Regulated Company and Supplier Activities

Module 7   : Quality Risk Management 

Module 8   : Testing

Module 9  : Operational Phase

Learning Objectives

This computerised systems validation training course covers the essential principles on how to use a risk-based approach in Computerised Systems Validation (CSV) using GAMP guidance approach.  

Who Should Attend

Quality Assurance and Quality Control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers and all levels of management who need a fundamental understanding of computerized system compliance and regulations.