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How to prepare for Computer Software Assurance – Webinar

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 Additionally, you will learn about the FDA-draft guidance that will stimulate critical thinking and the transition to Computer Software Assurance.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):

  • What is Computer System Validation (CSV)?

  • Why is CSV important? And what would happen if you don’t perform it?

  • Which requirments do regulatory agencies pose on Computer System Validation?

  • Which of your systems need to be validated?

  • How to assess criticality?

  • What are the key steps when implementing a computer system validation process?

Some topics we will discuss in the second half (CSA):

  • How does CSV differ from CSA

  • How to prepare for CSA

  • Risk-based approach to CSA

  • Transitioning to CSA

Interested in the webinar? Save your spot here!

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