GMP Update Seminar (incl. GDP)

Johan Hamminga is an experienced QA manager, consultant, trainer and auditor with more than 30 years of experience in quality assurance within the pharmaceutical and biotechnological industry. He has extensive expertise in GMP and GDP and broad experience with Quality Management Systems and regulatory inspections.

Since 2016, Johan has been active as Principal Consultant and Owner of Havem Pharma Consultancy, where he supports organisations with GMP and GDP compliance, preparation for and follow-up of regulatory inspections, CMC support, and the execution of audits and training. In addition, since 2021 he has been working with PCS as a Trainer and Consultant.

Previously, Johan held senior positions such as Director Quality Assurance at Allergan and Director Quality Assurance & Regulatory Affairs at Life Technologies. With his pragmatic approach, he supports organisations in improving quality and compliance within regulated environments.

Expertise and Services

• GMP and GDP
• Quality Management Systems (QMS)
• Regulatory inspections (preparation and follow-up)
• Responsible Person (RP)
• GMP and GDP audits
• GMP, GDP and Data Integrity training
• CMC support
• Project management

Positions

• Trainer & Auditor – PCS (2021–present)
• Principal Consultant / Owner – Havem Pharma Consultancy (2016–present)
• Consultant QMS & Responsible Person – Univar Solutions
• Head of QA Wholesale & Central Filling (a.i.) – Alliance Healthcare Netherlands
• QA Manager & Responsible Person – Brocacef
• Director Quality Assurance – Allergan
• Director Quality Assurance & Regulatory Affairs – Life Technologies
• Senior Project Manager / Compliance Manager – DSM Biologics

Education

• Bachelor of Science (BSc), Higher Laboratory Education (Immunology)
• Executive MBA – Nyenrode Business University

Skills

GMP • GDP • Quality Management Systems (QMS) • Regulatory Inspections • Responsible Person (RP) • Auditing • Training • CMC Support • Project Management

LinkedIn

https://www.linkedin.com/in/johanhamminga/

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/

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/

Anna-Myra Koopmans is a highly experienced GMP and sterile manufacturing professional with over 30 years of expertise in Quality Assurance, aseptic production and Qualified Person (QP) roles within the pharmaceutical and biotech industry. She is known for her decisive, results-driven approach and strong focus on inspection readiness and sustainable quality culture.

Since 2025, Anna-Myra has been working as an Independent GMP-QA Consultant, Trainer and Qualified Person at AMK Compliance Insight, supporting organizations with GMP compliance, sterile manufacturing, audit preparedness and strengthening Quality Culture. Prior to this, she served for nearly ten years as Director QA/QP at BioConnection, a CMO specialized in sterile products.

Expertise and services

• Sterile (aseptic) manufacturing – liquid and lyophilized products
• Contamination Control Strategy & Annex 1 compliance
• Aseptic Process Simulations (APS / media fills)
• GMP compliance, inspection readiness and audit preparation
• Internal and external audits & supplier qualification
• GMP training (QA, QP, CCS, sterile manufacturing)
• Qualified Person (QP) services for clinical and commercial products
• QA oversight of cleanroom and sterile equipment construction projects
• Quality culture and quality improvement projects
• Validation and qualification

Positions

• Independent GMP-QA Consultant / Trainer / QP – AMK Compliance Insight (2025–present)
• Director QA/QP – BioConnection B.V. (2016–2025)
• Qualified Person & Process Lead – MSD / Organon (2003–2016)
• Section Leader QA / Quality Systems – Organon
• Production Pharmacist – Organon (Parenteral & Special Products)
• Quality Officer & Validation Specialist – Organon

Education

• Pharmacist – Utrecht University

Skills

GMP • Sterile manufacturing • Qualified Person • Quality Assurance & Quality Systems • Annex 1 • APS / media fills • Inspection readiness • Audits • Validation • Quality Culture

LinkedIn

https://www.linkedin.com/in/anna-myra-koopmans-hoven-6716a720/