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 methadalogy.
Trainer Profile
TP Lowry has over thirty years in medical device and pharma industries working as Analyst, Engineer, Quality Manager to Operations Director. Consultant for the past sixteen years. MBA, Doctor of Quality Management