How to Validate AI/ML in Life Sciences, the Future of Computer System Validation
How to Validate AI/ML in Life Sciences, the Future of Computer System Validation
Free webinar, in English, via Zoom
06/NOV/2025
3:00 pm Central European Time (CET) | 11:00 am Brazil Time | 9:00 am US Eastern Time
Duration: 90 minutes
Artificial Intelligence and Machine Learning are transforming the Life Sciences industry. But how can we validate these technologies under GxP requirements?
What do regulators expect, and how do frameworks such as GAMP5® 2nd Edition and the EMA Annex 22 draft reshape validation strategies?
Watch this exclusive webinar, where our experts cover:
- Practical steps to validate AI/ML in GxP-relevant applications
- Key insights and industry comments on the EMA Annex 22 draft for AI in GMP
- How risk-based approaches accelerate compliance without compromising quality
- How AI/ML integration is changing the future of validation
We also officially launched our new training program:
“Modern Computer System Validation (CSV) in Life Sciences: GAMP5® 2nd Edition, FDA CSA, and AI/ML Integration”, designed for QA, IT, and business leaders/key-users seeking to upgrade their validation practices to the digital era.
Who organized this event?
FIVE Validation: Provides a digital validation platform for Life Sciences companies, accelerating validation studies up to 7 times faster with efficiency. This advancement is essential for the pharmaceutical, biotechnology, and medical device sectors, where several types of validation ensure compliance with EMA, FDA, WHO and ANVISA regulations.
Silvia Martins
Silvia Martins is an electrical engineer with over 23 years of experience in the pharmaceutical, biotechnology, and medical device industries. She has received specialized training in GAMP5® and FDA 21 CFR Part 11 in England, SAP® validation in Germany, and gained expertise in data integrity and governance in Denmark.
As the CEO and co-founder of FIVE Validation, a company dedicated to simplifying compliance processes, Silvia focuses on optimizing and streamlining client procedures while ensuring robust and compliant solutions.
Lilian Ribeiro
Lílian Ribeiro is a chemical engineer, biomedical systems technologist, postgraduate in Integrated Management Systems, and MBA in Data Science and Business Analytics. Lílian has over a decade of technical and commercial experience in the food, pharmaceutical, and healthcare industries. As an advocate for paperless validation, she is passionate about introducing efficiency and innovation into Life Sciences companies. Lílian's vast experience is fundamental in validation and qualification projects, encompassing digital validation tool, ERP, eQMS, automation (PW), and IT infrastructure qualification.
GAMP5® is a guide that has its intellectual rights reserved by ISPE®. Available for purchase at https://ispe.org/.
