This GAMP®5 – 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 latest guidance is based on a risk management approach and the course will also introduce them to some risk assessment techniques.
Course Content:
Introduction to GAMP® guidance
- History & background
- Purpose
- Scope
- Benefits
Detailed review of the Life Cycle approach & Phases, including
- Computerised system lifecycle
- Concept
- Project
- Planning
- Specification, configuration, coding
- Verification
- Reporting and release
- Supporting processes
Operation
- Handover
- Service / Incident / Change management
- Audits & Review
- Continuity / Disaster Recovery
- Administration & Security
- Record Management
Retirement
- Decommissioning
- Data migration
Introduction to Quality Risk Management
- Overview of Quality Risk Management
- Risk assessment process and techniques
Review of Regulated Company Activities
- Governance
- System Specific activities
Review of Supplier Activities
- Good practices / Quality management / Planning
- Specification / Documentation
- Sub-supplier management
- Design reviews
- Testing
- Brief review of Efficiency improvements
- Establishing objective requirements
- Using risk-based decisions
- Leveraging supplier input
- Efficient Testing
Brief review of Guidance’s / Appendices
This GAMP®5 – Risk Management Approach training programme may be of interest to anyone working in regulated industries in Quality / Validation / IT / Design or related roles.
Classroom based, instructor lead, practical hands on course.
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