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GAMP 5 Risk Management Approach

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GAMP 5 Risk Management Approach

This GAMP Risk Management Approach training course is a 1 Day public programme, designed to guide participants through the latest GAMP Guidance and give them a good understanding of the current best practices for GxP compliant computerised systems in regulated environments. It will enable them to understand and interpret the key requirements for their organisation to ensure that their computerised systems are fit for their purpose and meet regulatory requirements. The GAMP 5 Risk Management Approach training course provides the attendances with guidance that is based on a risk management approach and the course will also introduce them to some risk assessment techniques.

20/03/2025

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295.00

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Risk,Management,Strategy,Plan,Finance,Investment,Internet,Business,Technology,Concept.

Course Content:

  • Introduction & Course Objectives
  • Introduction to GAMP® guidance
  • Detailed review of the Life Cycle approach & Phases, including
  • Operation
  • Retirement
    • Decommissioning
    • Data migration
  • Introduction to Quality Risk Management
  • Overview of Quality Risk Management
  • Risk assessment process and techniques
  • Review of Regulated Company Activities
  • Review of Supplier Activities
  • Brief review of Guidance’s / Appendices
  • Q&A
  • Conclude & Follow Up Process