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.

The GAMP® 5 (3 Day) Training goes beyond our Fundamentals of GAMP® 5 Guidance by investigating in depth the main topics in the latest version of GAMP® 5: A Risk-Based Approach to Compliant GxP Computerised Systems, and reviewing sample appendices from the following sections: Development, Management, Operation and Special Interest Topics.

Taking the opportunity to attend this course is useful for people working in healthcare manufacturing and related IT departments. Suppliers can also benefit. National Blood Service employees and other industries such as bank ATM manufacturers have also attended this course.

So if you want a full working understanding of current regulatory thinking on computerised systems in industry, for IT, process control systems and manufacturing/packaging equipment, why not attend our course?

Content:

Day 1

• Investigate the reasons for the GAMP® 5 version update

  • Industry developments

  • Regulatory drive including Quality Risk Management, ICH Guidance and integration into QMS

  • Latest terminology and common themes including 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

  • Main article and contents

  • Appendices

• Review the life cycle approach and phases, including: life cycle concepts; concept, project and retirement

  • Project

    • planning

    • specification

    • configuration and coding

    • verification

    • reporting and release

    • support

  • To include practical examples based upon GAMP® categories of software

  • Operational phases including

    • Handover

    • CAPA

    • Change management

    • Security and system administration

• Introducing Quality Risk Management

  • An overview of Quality Risk Management including:

    • Integration to the QMS

    • The process itself and links to ICH Q9

• Describe regulated company activities to assure computerised system compliance

  • Elements to achieve compliance

    • Policies and procedures, roles and responsibilities

    • Training, managing supplier relationships, system inventories and specific activities

• Develop understanding of guidance on supplier activities

  • View help for suppliers; non configured product, configured product and custom package

  • Investigate supplier best practices

Day 2

• Consider guidance on efficiency improvements

  • Specific points in determining objective user requirements

  • Utilise risk assessment practice to determine life cycle activities

  • Influence supplier input and maximise use of own documentation

  • Effective testing and system handover

  • Operational activities

• Review main article topic 4, Life Cycle Phases, related Management Appendices

  • M1 Validation Planning

  • M2 Supplier Assessment

  • M4 Categories of Software and Hardware

  • M5 Design Review and Traceability

  • M7 Validation Reporting

  • Investigate changes to appendices and also new management appendix M10

• View appendix M3 Science Based Quality Risk Management relative to article 4 and 5 in the main contents of the guide

  • Roles and responsibilities

  • Guidance and examples for different categories of systems

Day 3

• Research remaining appendices

  • D2 Functional Specification

  • D3 Configuration and Design

  • D4 Incident Management

  • D5 Testing relative to article 4

• Check revised appendices and new appendices

  • D6 System Description

  • D7 Data Migration

• Develop understanding of new Operational Appendices covering

  • O1 Handover

  • O4 Incident Management

  • O5 CAPA

  • O7 Repair Activity

  • O12 System Administration

• Investigate the special interest topics appendices

  • S1 Alignment of ASTM E2500

  • S2 Electronic Production Records

  • S3 End User Applications

  • S4 Patch Management

  • S5 Managing Quality within an outsourced IS/IT environment

  • S6 Organisational Change

• Review of G1 GAMP® Good Practice Guides