How to survive an inspection?

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.

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.

Bart Dewolf

Head of Data Integrity & Digital Compliance

Bart Dewolf is Head of Data Integrity & Digital Compliance, with a solid foundation in auditing and quality oversight. Formerly leading audit functions, Bart brings deep expertise in regulatory compliance, data integrity programs, and digital systems validation. His approach is pragmatic and risk-based, focusing on building inspection-ready frameworks that work in practice—not just on paper. Known for his strategic mindset and collaborative leadership, Bart partners across teams to embed quality and compliance into digital transformation initiatives.

Ron van Uden

Compliance, Byondis

Ron has over 20 years of experience in the pharmaceutical Industry as a CSV engineer, QA-IT and IT/OT Compliance Lead within Organon, Schering-Plough, MSD and Byondis.

Joost den Iseger

Quality Assurance Officer

Joost den Iseger has been working for a decade in the Health / Biotech industry, mainly in start and scale-ups. By training a biologist and by heart a ‘quality-ologist’. Some companies Joost has worked for include Nutricia, Philips, HUB organoids and most recently myTomorrows. For the last 6 years he has been involved in designing, implementing and validating Quality Systems such as quality management systems, laboratory information management systems and learning management systems both from a content point of view and a validation point of view, most recently in line with best practices such as GAMP5. Currently working at myTomorrows where he is implementing an eQISMS called Bizzmine utilizing ModernRequirements4Devops along with René as the CSV specialist.

Richard Abbink

Business Manager Life Sciences

Richard is Business Manager Life Sciences at KEMBIT. Richard is a seasoned manager with a proven track record in bridging business requirements and IT delivery within international pharmaceutical organisations. After having spent a couple of years in Industrial Automation, he started his career in Life Sciences in 2001 by joining Organon in Oss as a business analyst in R&D IT. In the years that followed he held various positions as a project and team manager ranging from R&D to Manufacturing IT. Over the last 6 years he was the Site Digital Technology Lead at MSD Animal Health in Boxmeer. Richard is particularly passionate about enabling organizations to achieve excellence by implementing the right IT and automation systems to optimize processes.

Sandra van der Poel-Smet

Sandra van der Poel-Smet is a seasoned QA expert with over 30 years of experience in pharmacovigilance and GCP. She has held key roles including Principal Consultant, Managing Director, and Head of PV Operations, and served as a QPPV. Sandra has led global PV system integrations, audits, and compliance efforts across Europe, North America, and Asia. Her LEAN-driven approach emphasizes simplicity, efficiency, and collaboration.

Roy Verhoeven

Vivenics Consultancy

Roy Verhoeven is Data Compliance consultant at Vivenics. With nearly a decade of experience in the Life Sciences and a legal/compliance background, he supports pharma and biotech organizations to meet GxP, GDPR, and cybersecurity requirements. Together with Optimum Quality, Roy focuses on CSV/CSA in a digital, record-based way. He is also a board member of the ISPE GAMP CoP Benelux.