What they don’t teach you in CSV training

James Ainsworth March 6, 2021 119 5

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James Ainsworth is a software developer who started supporting businesses with ERP deployment and CSV about ten years ago. Besides the pharmaceutical and biotech sectors, James has experience consulting companies in other highly regulated industries such as Automotive and Fintech.


In this podcast episode, James spoke to Yan Kugel about CSV and its essential parts, about which you don’t learn in training. 

Here are some of the topics you will hear about:

  • The most challenging parts of CSV are not what you think they are.
  • The real objectives of CSV.
  • What’s more critical in CSV than CSV?
  • What is the role of the QA in CSV?
  • What are the functions of the CSV lead?
  • How to manage stakeholders? 
  • The reasons why companies should hire external CSV leads.


Gain insights into why your organization encounters delays to system validation projects and learn strategies for building effective working relationships between QA and CSV representatives to overcome common validation challenges. The strategies will help you improve system delivery, compliance, and harmony at the workplace.

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