Course description
The need for digitalization in the pharmaceutical laboratories is continuously evolving & there is a need for a more unified approach to laboratory and data management.
Leading pharmaceutical and biotech companies are reassessing the processes and digital tools (incl. information systems) they use to collect, handle and organize QC laboratories data. The draft updates of EU GMP Annex 11 and Chapter 4 change the regulations from interpretive to prescriptive and Annex 22 on Artificial Intelligence takes a different approach to the FDA.
This practical course provides an in-depth understanding of current and proposed regulations and guidance to enable attendees to redesign and digitalize processes. In parallel, practical, flexible and efficient computerised system validation is essential to ensure a return on company investment. We will focus on how to leverage supplier development and testing to reduce your overall CSV effort. Change control of computerised systems is important to keep current and reduce cybersecurity vulnerabilities.
Join us & enhance your digital laboratory automation journey to achieve greater innovation, collaboration & productivity.
