GMP Update Seminar (incl. GDP) 2026

Wilma Meijs is an experienced consultant and director with more than 25 years of experience in the pharmaceutical industry. She has a strong focus on GMP, GxP and Quality Management Systems, and extensive experience in QA, QC and QP roles within both small molecule and biotechnological environments.

Since April 2011, Wilma has been the owner of Wilma Meijs Farmaceutisch Advies BV, where she supports pharmaceutical companies with GxP compliance. Her activities include validation projects, acting as a Qualified Person (QP), implementation and improvement of Quality Management Systems, performing audits, and developing and delivering training programmes.

Previously, Wilma held various QA, QC and management positions at, among others, Intravacc, Abbott Biologicals, PCS, the Netherlands Vaccine Institute, AMT Biopharma, Merck Sharp & Dohme, Biogen Idec and Teva Europe.

Wilma obtained her PhD at Vrije Universiteit Amsterdam and combines her academic background with extensive hands-on experience in quality assurance and pharmaceutical manufacturing.

Expertise and Services

• GMP & GxP
• Quality Assurance & Quality Control
• Qualified Person (QP)
• Validation of processes, cleaning and equipment
• Implementation of Quality Management Systems
• Auditing (internal and external)
• Training & coaching
• Risk assessments and environmental monitoring

Positions

• Consultant & Director – Wilma Meijs Farmaceutisch Advies BV (2011–present)
• QP at a radiopharmaceutical company
• QP at gene therapy companies
• QP at vaccine manufacturing/ biotech companies
• QP at cell therapy companies

Education

• PhD – Radiopharmacy / Medicines, Vrije Universiteit Amsterdam
• MSc – Biochemistry

Skills

GMP & GxP • Quality Assurance & Quality Control • Qualified Person (QP) • Validation • QMS  • Auditing • Training

LinkedIn

https://www.linkedin.com/in/wilma-meijs-1229a98/

Jaap Koster is a highly experienced Executive Consultant, Project Director and auditor with more than 40 years of international experience in the pharmaceutical and biotechnological industry. He specialises in GMP/GDP, crisis management, quality management, facility design and inspection readiness, with a strong focus on vaccines and other biotechnological products.

Since 1999, Jaap has been active a as consultant. Since 2009 he has been the CEO and Executive Consultant of PCS – Pharmaceutical Consultancy Services, where he supports organisations worldwide in the implementation and improvement of GMP facilities and Quality Management Systems. He regularly acts as Project Director for new build and refurbishment projects, interim QA Manager and Lead Auditor, and has been delivering GMP and GDP training (public and in-house) since 2003.

Jaap has extensive experience in crisis management and requalification after regulatory disapproval, including successful WHO requalification projects in Asia. In addition, he played a key role in the first worldwide implementation of EU GMP for medicinal cannabis. His international project experience spans Europe, the United States, India, Asia, South-America and Africa.

Expertise and Services

• GMP & GDP
• Vaccines & biotechnological products
• Facility design & refurbishment (including BSL-3 and aseptic facilities)
• Quality Management Systems
• Inspection readiness (FDA / WHO / EU)
• GMP & GDP auditing
• Training & quality culture
• Project and interim management

Positions

• Executive Consultant / CEO – PCS Pharmaceutical Consultancy Services
• Project Director – international GMP and vaccine facility projects
• Interim VP Quality / Head Corporate QA – USA & India
• Interim Managing Director within a range of organisations
• GMP Lead Auditor – international pharmaceutical organisations

Education

• Chemical Engineering – Delft University of Technology
• Manufacturing Engineering – HTS Breda
• Qualified Person (EU)
• Certified GMP & ISO Lead Auditor

Skills

GMP & GDP • Vaccines & biotechnological products • Quality Management Systems (QMS) • Facility design & refurbishment (aseptic / BSL-3) • Inspection readiness (EU / FDA / WHO) • Cross-Contamination Control Strategy (CCS/CCAS) • GMP & GDP Auditing • Project & Interim Management • Crisis Management • Training & Quality Culture

LinkedIn

https://www.linkedin.com/in/jaap-koster-0991077/

Eric van Wensveen is an experienced professional with over 40 years of experience in the pharmaceutical industry. He began his career in Research & Development and later served as the responsible Head of Quality for (radio)diagnostics and medicinal products, including membership of the management team. Eric specializes in EU and FDA GxP and has extensive experience with manufacturing and quality systems in an international context, supported by global export activities.

Since 2022, Eric has been the owner of the consultancy firm adQvice, where he supports organizations as a consultant, auditor, Qualified/Responsible Person (QP/RP), and trainer. He provides advisory services and delivers training in the areas of EU/FDA GMP compliance and manufacturing and quality management systems. Prior to this, he held senior positions at Curium and Mallinckrodt Pharmaceuticals, where he led the quality organization (50+ FTE) and was ultimately responsible for QA, QC, batch release, validation, and quality systems.

Expertise, Skills and Services
• EU & FDA GxP compliance
• Aseptic and terminally sterilized manufacturing (Annex 1)
• Quality systems (including Change Control, deviation and CAPA management)
• Quality Control and Sterility Assurance Management (including OOS/OOT)
• Batch release, Qualified Person (QP/RP)
• Validation and risk assessments
• Auditing
• Training and coaching
• (Quality) management

Professional Experience
• Director – adQvice (2022–present)
• Director Quality – Curium (2003–2022)
• Senior Project Leader R&D – Mallinckrodt Medical BV (1981–2003)
• Qualified Person (2006) / Responsible Person (GDP) (2014)

Education
• MSc Environmental Science / Management – Open Universiteit Nederland
• BSc Analytical Chemistry – Bakhuis Roozeboom Instituut
• Postgraduate program – Quality Management in Pharma/Biotech (LACDR / GUIDE / BODL / EUFEPS)

LinkedIn
https://www.linkedin.com/in/eric-van-wensveen-a077bb19/