Modern Computer System Validation (CSV) in Life Sciences: GAMP5® 2nd Edition, FDA CSA, and AI/ML Integration
This course includes
Progressive Discount
2-5 Attendees
-5%
6-10 Attendees
-10%
11-15 Attendees
-15%
More than 16 Attendees
-20%
What you will learn
Description
This online course offers on-demand videos, allowing you to learn at your own pace with over 100 lessons. Whether you're a beginner or a professional, you'll gain knowledge on Computer System Validation (CSV), including regulations, GAMP5® guidelines, FDA CSA, and the impact of Industry 4.0 technologies.
The course covers the validation process, agile methods, digital validation strategies, and AI/ML validation, focus
This online course offers on-demand videos, allowing you to learn at your own pace with over 100 lessons. Whether you're a beginner or a professional, you'll gain knowledge on Computer System Validation (CSV), including regulations, GAMP5® guidelines, FDA CSA, and the impact of Industry 4.0 technologies.
The course covers the validation process, agile methods, digital validation strategies, and AI/ML validation, focusing on data integrity, security, and compliance in regulated industries.
With 24/7 access, you can watch the lessons whenever it suits you, and you'll have 1 year of unlimited access to the course across any device—whether it's a computer, tablet, or mobile. This course is perfect for anyone looking to enhance their skills or begin a career in validation.
About the instructor
Silvia is an electrical engineer with over 23 years of experience in the Life Sciences industry, primarily in the biotech, pharmaceutical, medical device, and cosmetics sectors. She brings an international background with specialized training in GAMP5 and FDA 21 CFR Part 11 in England, SAP® validation in Germany, and data integrity and governance in Denmark.
As CEO and co-founder of FIVE Validation, she leads a company dedicated to simplifying regulatory compliance and is the visionary behind GO!FIVE, the digital validation platform. Her work is centered on accelerating and streamlining clients’ processes while ensuring robustness and regulatory compliance.
Attendee feedback
Reviews
Amanda Nogueira
Highly technical content, very well explained and developed by the instructor. The program is comprehensive and prepares professionals for the real challenges of computer system validation! An excellent investment for leaders and their teams!
Bruna Barros
Excellent course! Clear, practical, and up to date with the latest in CSV, GAMP5 2nd Edition, and AI/ML. Highly recommended.
Carolina Fanti
Very complete and easy to understand. Thank you!
Viviane Araujo
I’m at the beginning of the course and really enjoying it. The content is clear and well-structured, making learning easier. I have high expectations for the next modules.
Deivid Lopes
Bruna Pereira
Diego Ferreira
Ramon Assis
Lilian Ribeiro
I must say, I was thoroughly impressed with the content offered. The insights into Industry 4.0 and trending technologies impacting validation added a forward-thinking approach that I greatly appreciated.
Flavienne Soares
Curso completo e muito bem detalhado para as atividades de validação!
Maria Oliveira
The CSV course was very well structured and covered the full computerized systems lifecycle and key documentation. It also gave a modern and relevant overview of topics like Industry 4.0 and AI. The training was clear, practical, and easy to apply to daily work. Thank you very much.
Maria Eduarda Carrupt de Almeida
Amazing and valuable content! The course provides a clear and practical understanding of modern CSV aligned with GAMP 5® 2nd Edition and FDA CSA principles, with the inclusion of AI/ML topics adding strong value and future relevance. Thank you, Silvia, for translating the technological revolution we are witnessing into clear, actionable insights. Highly recommended for life sciences professionals!
Mariana Vargas Laterça
Just finished the course and really enjoyed it! Very well-designed with current coverage of modern CSV. The teaching approach is clear and engaging, and the discussions about Pharma 4.0, regulatory expectations, AI/ML integration, and the validation process itself provide valuable insights. Strongly recommended.
Gabriel Keller
Caroline Pires
Very educational course, excellent support material
Camile Sória
O conteúdo é extenso e profundo. Ao mesmo tempo, é fácil de acompanhar e entender.