To provide learners with an overview of the basics of the New Good Automated Manufacturing Practice (GAMP® 5) guidelines and approaches.

The course will establish what GAMP® 5 is and how it can be applied within organisations.

The course is suitable for learners with little or no knowledge of GAMP® 4.

• Identify how GAMP® guidance was developed and the reasons behind it
• Regulatory requirements
• Technological innovation
• Interpretation of rules and regulations
• Review the Life Cycle approach and phases, including: Life cycle concepts; concept, project and retirement
• Practical examples based upon GAMP® categories of software
• Operational phases including:
• Handover
• CAPA
• Change management
• Security 
• System administration
• Latest terminology and common themes including, the relationship between qualification terminology and GAMP® 5 activities
• V model approach for IT systems and process control systems
• Categories of software, hardware and the validation approach
• Introducing Quality Risk Management
• An overview of Quality Risk Management
• Description of the risk assessment process including sample risk assessments
• Develop understanding of guidance for supplier activities
• Consider help for suppliers
• Describe regulated company activities to assure computerised system compliance
• Elements to achieve compliance
• Regulatory approach to audits and non-compliance
• Areas particularly vulnerable to non-compliance for manufacturers, and supplier considerations
• Review other GAMP® 5 guidance articles and appendices including:
• Guidance on efficiency improvements 
• Appendices: 
• Management
• Development
• Operation
• Special Interest Topics
• Other General Appendices

ISPE owns the GAMP® trademark http://www.ispe.org/