Who is the course for

This course is most suitable for those who wish to gain a good understanding of the principle and processes involved in computerised software validation and regulatory requirements.

Learning outcomes

Learners will have a complete understanding of why Computer Validation is necessary and have a better understanding of the process of providing documented evidence that an electronic system or technology will perform as specified.

Content

• Introduction to principles of validation, IQ, OQ, PQ, etc.
• Review of regulatory requirements
• Review of GAMP Guidelines
• Risk Analysis
• Categorisation of the computerised system & validation requirements
• Guidelines for determining validation effort with risk assessment
• Approach to new equipment and introduction of new equipment – “Life Cycle Approach”.
• Responsibilities within the validation project team.
• FMEA – a tool in validation approach.
• Validation Documentation: SOP, URS, SDS, FDS.
• Computerised Systems Life-cycle Project Phases.
• Categorisation of the computerised system & validation requirements
• Guidelines for determining validation effort with Risk Assessment Case Studies / Examples will be included in order to best communicate the methodology.