The course compares the GAMP® 5 guidance with the previous version and provides the learners with an understanding of the differences.

This course is suitable for learners with previous knowledge and experience of GAMP® 4.

• Investigate the reasons for the GAMP® 5 version update
• Industry developments
• Regulatory drive
• Latest terminology and common themes including the relationship between qualification terminology and GAMP® 5 activities
• Compare the differences between GAMP® 4 and GAMP® 5
• Cross referenced table of differences
• Look at key concepts in the GAMP® 5 guidance
• Main article and contents
• 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
• Introducing Quality Risk Management
• An overview of Quality Risk Management
• Describe regulated company activities to assure computerised systems' compliance
• Elements to achieve compliance
• Develop understanding of guidance on supplier activities
• Consider help for suppliers
• Consider guidance on efficiency improvements including:
• Specific points in determining objective user requirements, risk assessments,  influencing supplier input, use of own documentation, effective testing, and system handover
• Operational activities
• Introduce new and revised appendices including:
• Management
• Development
• Operation
• Special Interest Topics
• General Appendices

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

ITS’ Regulatory Training Manager, Alan Benbow, has developed extensive knowledge of this specialist area from 22 years’ industry experience working with Johnson & Johnson, and Wyeth Pharmaceuticals.

During his 14 years at Wyeth, Alan was involved in a wide range of activities including, at operational levels, developing operators, craftsmen, and technicians; he was also responsible for training and assessing operational employees to NVQ standards. From a mid-management perspective, training and development initiatives included facilitating continuous improvement projects and best practices, and receiving internal recognition awards. more ›