Overview:

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.

Content:

• 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