Different perspectives on SAAS Validation
Join us on the 19th of June 2025 at UCB, Anderlecht (BE), for an exciting GAMP event on the “validation of SaaS systems”. With this event we want to highlight the collaboration between regulated companies and SaaS suppliers and give you insights in how SaaS systems can be validated and maintained.
Learn from experts in the field in how to manage SaaS vendors and what measures you can take to ensure a SaaS system is maintained in a validated state.
Topics on the agenda are:
- Multiple use cases on the validation of Saas systems by the vendor.
- Auditing of Saas solutions
Attendees will have the opportunity to ask questions and gain valuable insights from experts in the field. Don't miss out on this opportunity to network with industry leaders and gain a deeper understanding of the future of the life sciences industry. Register now on our website and be at the forefront of innovation!
This event is held at UCB, Researchdreef 60, 1070 Anderlecht, Belgium, who are so kind to sponsor the facilities, drinks, and food.
The event is open for both ISPE members (free of charge) and non-ISPE members (€40). Registration is required.
We recommend coming by public transport, as parking in the area is limited.
If you do plan to come by car, please allow some extra time to find street parking. Rue de Recherch offers free parking, while Lenniksebaan requires a blue parking disc or paid parking. There's also the BePark Erasmus parking garage available within a 5-minute walk (paid).
Event Properties
| Event Date | 19-Jun-2025 14.00 |
| Event End Date | 19-Jun-2025 20.00 |
| Capacity | 100 |
| Registered | 34 |
| Individual Price | €40.00 |
| Location | UCB |
Agendas
| 13:30 |
Welcome & Registration |
| 14:00 |
Welcome - GAMP CoP BeneluxNatasje Bastiaens - GAMP CoP |
| 14:05 |
Introduction UCBSpeaker UCB |
| 14:15 |
Difference between on prem vs SAAS validation - pro & cons, additional risksTom De Rudder |
| 14:35 |
Auditing of SAASJeroen Leemen |
| 15:05 |
Bizzmine eQMS validation use caseRené van Opstal (Optimum Quality); Jordy Gouw (Bizzmine); Arno de Beer (Bizzmine) |
| 15:35 |
Use Case: Implementation of Veeva Quality at UCBKristel Borremans and Waseem Shahid |
| 16:05 |
BREAK |
| 16:35 |
GxP Validation in Cloud Data Platforms: Bridging the Compliance Gap in the Absence of a QMSShikha Raikundalia |
| 17:05 |
Cloud securityHans de Raad |
| 17:35 |
How to validated SAAS following GAMP 5, 2nd editionNatasja Bastiaens |
| 18:05 |
Q&A, Wrap-up & closingNatasje Bastiaens; Niels De Blende |
| 18:30 |
Dinner and Networking |
Speakers
Natasja Bastiaens
GAMP COP Benelux - Chair
Natasja is a demonstrated people leader with 20+ years of experience in the life sciences industry covering different roles and expertise’s, a.o.:
- managed and coached team members in setting up and developing computerized system validation projects incl. Cybersecurity
- provided different types of training (e.g. overall CSV, IT regulations, GAMP 5, SDLC, supporting processes,...)
- acted as project manager in different GxP related projects
- acted as internal and external licensed lead auditor for different Computerized System, IT, Infrastructure and Cyber Security related processes.is a demonstrated people leader with 20+ years of experience in the life sciences industry covering different roles and expertise’s, a.o.:
- managed and coached team members in setting up and developing computerized system validation projects incl. Cybersecurity
- provided different types of training (e.g. overall CSV, IT regulations, GAMP 5, SDLC, supporting processes,...)
- acted as project manager in different GxP related projects
- acted as internal and external licensed lead auditor for different Computerized System, IT, Infrastructure and Cyber Security related processes.is a demonstrated people leader with 20+ years of experience in the life sciences industry covering different roles and expertise’s, a.o.:
- managed and coached team members in setting up and developing computerized system validation projects incl. Cybersecurity
- provided different types of training (e.g. overall CSV, IT regulations, GAMP 5, SDLC, supporting processes,...)
- acted as project manager in different GxP related projects
- acted as internal and external licensed lead auditor for different Computerized System, IT, Infrastructure and Cyber Security related processes.
She`s part of the ISPE GAMP COP Benelux Board since 2018.
René van Opstal
Optimum Quality
René is a very experienced consultant in the field of process automation, Computer Validation, MES, system selection and advise. Beside that, due to his large experience in the execution of projects (from design, implementation and project management) he is capable of leading a large group of people in engineering teams or customer project teams.
The current focus is on content based digital validation of systems, Using Microsoft DevOps with Modern Requirements.
Tom de Rudder
Member ISPE GAMP Special Interest Group – Manufacturing Execution Systems (MES)
MSc Bio-Engineering (University Ghent) + 20 years working in Pharrma in project & team lead roles, with hands-on project experience in # areas (Manufacturing, QA/QC, IT, Supply Chain, ...) Current role as Manufacturing Systems Lead at Novartis Manufacturing site Puurs, with main focus on IT GxP – CSV, Project Management, Business Process Analysis (Lean/Continuous Imrpovement), SAP, MES, Master Data & Artworks Act as ISPE “volunteer” in GAMP Benelux (board member), GAMP SIG Data Integrity, MES, Pharma 4.0., and as ISPE Belgium Affiliate Board Member.
Arno de Beer
Global Account Manager at Bizzmine
Arno has over 15 years of experience working in QHSE Account Management, both nationally and internationally. Currently he is working as Global Account Manager at Bizzmine, servicing existing (Enterprise) clients and potential new customers that are interested in Bizzmine QHSE software. Prior to his start with Bizzmine in 2017, he worked at another software company where academic, top-clinical and regular hospitals were his clients.
Jordy Gouwy
Technical Customer Success Manager at Bizzmine
Jordy has over 15 years of experience working in IT (specialized in Quality Management Software). Currently he is working as Customer Success Manager at BizzMine, analyzing the needs of our customers followed by the implementation and training of our software. Keeping (new) customers happy is the main goal of his job. At the start of his professional career, he was Developer at the same company, where he built the Web Environment of Bizzmine QHSE solutions.
Jeroen Leemen
Quality & Compliance Engineer
Experienced Validation Engineer with a demonstrated history of working in the pharmaceuticals industry. Skilled in Good Laboratory Practice (GLP), Validation, GMP, Six Sigma, and Rapid Prototyping. Strong quality assurance professional with a Bachelor of Applied Science (B.A.Sc.) focused in Biomedical Technology/Technician.
Shikha Raikundalia
Clinical Trials & Pharma Expert | Driving Digital Transformation in Big Pharma
I am passionate about leveraging my expertise to lead digital transformation initiatives in Big Pharma, improving efficiency and ensuring high-quality, compliant systems that support critical decision-making processes.