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 Additionally, you will learn about the FDA-draft guidance that will stimulate critical thinking and the transition to Computer Software Assurance.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