Good Distribution Practices (GDP) – also for the Responsible Person (classroom)

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/

Ali Aziz is an experienced Qualified Person (QP), QA Specialist and Responsible Person (RP) with a strong background in the pharmaceutical industry. He has extensive experience in quality assurance, batch release and compliance within GMP- and GDP-regulated environments.

Since August 2023, Ali has been the founder and owner of Pharmali Consulting B.V., where he supports organisations as a QP/QA Specialist and RP Consultant. In addition, since November 2024 he has been working as Responsible Person at Pharmali Pharmaceuticals B.V., of which he is also a co-founder.

Ali is also active as a Qualified Person Consultant, including assignments at MSD Netherlands and previously at Abbott. Earlier in his career, he held positions at Janssen Biologics (Johnson & Johnson), MSD and Mylan, and worked as a locum pharmacist. From 2019 to 2023, he served as Treasurer of the Dutch Association of Industrial Pharmacists (NIA).

Expertise and Services

• Qualified Person (QP)
• Responsible Person (RP)
• Quality Assurance
• GMP and GDP
• Batch release
• Root cause analysis
• Document management
• Quality Management Systems

Positions

• Responsible Person – Pharmali Pharmaceuticals B.V. (2024–present)
• Founder / Owner – Pharmali Consulting B.V. (2023–present)
• Qualified Person Consultant – MSD Netherlands (2024–present)
• Qualified Person Consultant – Abbott
• Senior Associate / Qualified Person – Janssen Biologics (J&J)
• Qualified Person – MSD
• Senior QA Officer / QP / RP – Mylan

Education

• Pharmacist – University degree in Pharmacy

Skills

Qualified Person (QP) • Responsible Person (RP) • Quality Assurance • GMP • GDP • Batch release • Root cause analysis • Document management

LinkedIn

https://www.linkedin.com/in/ali-aziz-66629486/