Keeping current with the latest regulatory requirements and industry guidance can be a challenge when you have a hundred and one tasks to complete, but you can achieve it by taking just one day out of your working schedule to attend this catch-up course.
It will help unravel the main topics in the latest version of GAMP® 5: A Risk-Based Approach to Compliant GxP Computerised Systems, and help refresh existing knowledge and practice.
The GAMP® 5 course is ideal for those working in healthcare manufacturing and related IT departments, as well as suppliers. People employed in the National Blood Service and other industries such as bank ATM manufacturers, have also attended and benefited from this course.
Identify how GAMP® guidance was developed and the reasons behind it
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:
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
Special Interest Topics
Other General Appendices