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This course will provide you with an overview of what matters in validation of computerised systems (including CSA) to help your company meet regulatory requirements and mitigate risks to product quality and patient safety.
1 hour online/Zoom session: Discuss FDA Environment, 21 CFR Part 11 & PIC/S Annex 11. Explore areas of control within your company. Then discuss specific Annex 11 clauses relevant to your requirements.
1 hour online/Zoom session: Walk through a Computer System Validation Master Plan and an Infrastructure Qualification Plan to highlight the importance of the overarching validation framework.
2 hour online/Zoom session: Work through a macro risk assessment, then use it to discuss a CSA validation approach. Work through a full project validation example (validation plan, requirements, design and testing) highlighting how knowledge gained at the system testing can flow back into the end-user testing.
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