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

Pharmaceutical trainer, consultant, and coach with over 20 years of expertise in GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice). Karen Zimmermann helps pharmaceutical organizations enhance their level of quality and compliance by fostering a quality culture, leading to high-quality products and services.

As the owner of Connectives Learning, she assists passionate pharma professionals and consultants in becoming inspiring trainers, enabling participants to learn easily without them needing to possess all the knowledge themselves. Since 2015, Karen has been active at PCS - Pharmaceutical Consultancy Services as a pharmaceutical trainer, consultant, and coach.

She provides training in areas such as quality culture, human error reduction, train-the-trainer, risk management, batch documentation review, data integrity, GMP for middle management, GDP, and leadership in the pharmaceutical industry.

Additionally, she consults on various GMP/GDP-related projects and has collaborated with a wide range of pharmaceutical companies.

Previously, Karen was Quality Manager at Actavis (now Allergan), where she was responsible for the quality management system according to ISO, GMP, and GDP standards. She served as the Qualified Person for the packaging process and the Responsible Person for the GDP license. With her background in quality management and her passion for developing people and teams, Karen helps organizations reach a higher level of quality and efficiency within the pharmaceutical sector.

Pharmaceutical professional with over 40 years of expertise in the pharmaceutical industry, focusing on Quality Assurance (QA), Good Manufacturing Practice (GMP), and regulatory affairs. René Maassen has been the director of Pharmaceutical Consultancy Services (PCS) since 2003 - up to 2014, providing consultancy on all aspects of QA, GMP, and regulatory affairs in the pharmaceutical, biotechnology, and related healthcare industries.

Expertise and Services:

• Consultancy in QA, GMP, and Regulatory Affairs.
• Qualified Person (QP) under EU Directive 2001/83.
• Training and auditing for pharmaceutical companies.
• Support in setting up and implementing quality systems.

Previous Positions:

• Inspector for pharmaceutical companies at the Health Care Inspectorate (1996-2003):

  • Responsible for inspecting industrial manufacturing operations in the Netherlands and, upon request by the EMA, also outside Europe.
  • Head of the group of GMP and GCP inspectors.
  • Deputy Chief Inspector for Pharmacy and Medical Technology.

• Manager QA/QC and Qualified Person at Solvay Pharmaceuticals (1984-1996):

  • Responsible for quality assurance and quality control within the organization.

• Production Pharmacist at Solvay Pharmaceuticals (1981-1984):

  • Responsible for production processes and compliance with GMP guidelines.

• Community Pharmacist (1980):

  • Worked in two different public pharmacies.

Education and Qualifications:

• Pharmacist degree from the University of Amsterdam (1973-1980).
• Qualified as a Qualified Person under EC Directive 2001/83 since 1984.
• Member of the Society of Dutch Industrial Pharmacists since 1981.
• Member of the Parenteral Drug Association (PDA) since 1994.

Languages:

• Dutch: Native language.
• English: Fluent in speaking; proficient in writing.
• German: Fluent in speaking; proficient in writing.
• French: Working knowledge.