FDA and EMA Trends for Computer System Validation (CSV) – Compliance Strategies
Overview:
Silvia Martins, CEO, and co-founder of FIVE Validation has envisioned this session to help businesses better understand some important points that the second edition of GAMP5® and CSA bring and make us think about ‘how system validations will be from now on’.
Very special and skilled panelists will be present in this section where they will give precious tips and recommendations that can shorten your path to a successful project.
“By adopting agile methods, the aim is to save time, enhance agility, and avoid obstacles to innovation during the validation process.”, Silvia Martins.
What was discussed
The following topics were covered:
- What is validation and what is computer system validation?
- GAMP5 second edition
- FDA CSA
- Why GAMP5 and CSA can be good for business?
- Waterfall x Agile methods
- Tools instead of documents
- Paperless validation
¿Le falta tiempo para visualizar el seminario completo? Hemos confeccionado un resumen en vídeo de 8 minutos.
Speaker
Silvia Martins – FIVE Validation
Silvia Martins, electrical engineer, with 20 years of experience in serving biopharmaceuticals and medical devices companies. Trained in England in GAMP5 and FDA 21 CFR Part11, in Germany in SAP validation, and in Denmark in data integrity and data governance. CEO and co-founder of FIVE Validation, a promising company that aims to make compliance faster and simpler.
Special Guest – QbD Group
Jonathan Boel – QbD Group
Jonathan Boel is the Head of Software Solutions and Services at the QbD Group, with more than 10 years of experience in computer system validation, data integrity and general QA activities for different GxP and medical device industries. Jonathan Boel is also a Trainer, certified auditor and Senior Project Manager at QbD Group.
