GxP Compliance Webinar

How to ensure GxP Compliance for Computerized Systems 

Watch on-demand by filling out the form to the right

Join our webinar about GxP Compliance for computerized systems, where we will look at how to ensure compliance during implementation and maintenance of computerized systems in regulated industries like pharma, biotech and medical device.

We will discuss how to improve the process for GxP assessment and documentation which can be relevant when 

  • Implementing a new IT solution 
  • Using an existing IT solution 
  • Or ensuring inspection readiness 

This topic is important due to the increasing focus on GxP compliance for computerized systems by the FDA*. HERAX can assist in ensuring GxP compliance and correctly documenting IT solution(s) in an efficient and structured way. 

*(FDA: Guidance for Industry – Computerized Systems Used in Clinical Trials

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    Speakers

    Jakob Schmidt

    Jakob Schmidt

    Business Analyst

    Jakob is a pharma business and IT consultant. He specializes in validation and compliance. He also works with analyzing and optimizing pharmaceutical processes, developing quality documentation, and implementing process improvements. Jakob is focused and takes initiative to drive projects forward, working with people in all levels of an organization. He is highly motivated to solve problems with a high level of quality, driven by a strong analytical mindset. Jakob holds certificates for PRINCE II, GAMP5 and LEAN.