How to prepare for Computer Software Assurance – Webinar
Working towards GMP? Learn which of your computer systems require validation, which do not, how to implement this process successfully, and the key deliverables according to GAMP-5. In this webinar we will focus on the question: How to prepare for Computer Software Assurance?
This webinar is aimed at sharing best practices and insights into launching a computer system in your (almost) GxP company. Additionally, you will learn about the FDA-draft guidance that will stimulate critical thinking and the transition to Computer Software Assurance.
To help you on your way, we will also share a checklist during the webinar to assist your efforts in CSV and the transition toward CSA.
Some topics we will discuss in the first half (CSV):
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What is Computer System Validation (CSV)?
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Why is CSV important? And what would happen if you don’t perform it?
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Which requirments do regulatory agencies pose on Computer System Validation?
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Which of your systems need to be validated?
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How to assess criticality?
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What are the key steps when implementing a computer system validation process?
Some topics we will discuss in the second half (CSA):
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How does CSV differ from CSA
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How to prepare for CSA
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Risk-based approach to CSA
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Transitioning to CSA
