GMP Update Seminar (incl. GDP) 2024

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.

Experienced consultant and director with over 25 years of expertise in the pharmaceutical industry, focusing on GMP (Good Manufacturing Practice) and quality management systems. Wilma Meijs has been the owner of Wilma Meijs Farmaceutisch Advies BV since 2011, where she provides consultancy services in GxP for pharmaceutical companies.

Expertise and Services:

• Project Leadership in validation of processes and equipment.
• Qualified Person (QP) responsible for product release.
• QA Support for the development of new pharmaceutical products and production processes.
• Implementation of Quality Systems, including Trackwise.
• Conducting Internal and External Audits.
• Developing and Delivering Training Courses for pharmaceutical staff.
• Facilitating Risk Assessments and setting up environmental monitoring programs.
• Validation Support for production processes, cleaning validation, equipment qualification, and QC test implementation.

Previous Positions:

• QA/QP at Intravacc (2012-2015): Responsible for quality assurance and acting as Qualified Person.
• QA/QP at Abbott Biologicals (2007-2012): QA for the influenza development group, handling product complaints, and QP responsibilities.
• Consultant and Director at PCS (2004-2011): Various QA/QC positions for different pharmaceutical companies, including QP functionality and developing training programs.
• QA at Nederlands Vaccin Instituut (2005-2011): Support of the QA department, GMP improvement projects, and project manager for the implementation of QMS/DMS (Trackwise).
• QA/QC Manager at AMT Biopharma (2003-2004): Setting up and implementing quality systems for viral-based pharmaceuticals.
• QC Manager at Merck Sharp & Dohme (2000-2003): Daily management of the QC laboratory, responsible for analytical and microbiological analyses and environmental monitoring.
• QC Manager at Teva Europe (1995-1999): Managing routine QC analyses, technical transfers of QC tests, and setting up a laboratory for cytostatics.

Education:

• PhD in Radiopharmacy from VU University Amsterdam. Research focused on the development of new radiopharmaceuticals, with the thesis titled: "The suitability of Zirconium-89 for labelling of antibodies for positron emission tomography".

Jaap Koster is a pharmaceutical professional with over 40 years of extensive experience both in the Netherlands and internationally. Since January 1999, he has been the Executive Consultant and Owner of PCS - Pharmaceutical Consultancy Services, a global firm specializing in GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) consultancy, training, audits, and software solutions. In this role, Jaap has directed numerous projects involving the implementation of new and refurbished pharmaceutical facilities, including Quality Management Systems (QMS). He has also served in interim leadership positions such as Vice President of Quality in the United States for five years and Head of Corporate Quality Assurance in India for seven years.

Jaap's expertise is particularly pronounced in the field of vaccines and novel biotechnological products. He has been instrumental in leading cross-contamination avoidance strategies for shared facilities handling multiple biological active substances and products. His leadership was pivotal in guiding companies through inspection readiness programs for WHO inspections and achieving GMP compliance after periods of non-compliance.

Notably, Jaap played a significant role in implementing GMP standards for medicinal cannabis, marking the first global achievement of EU GMP certification for a medicinal cannabis manufacturer. He has also held the position of Director and Responsible Person at Tetris Pharma B.V., contributing to the company's compliance and operational excellence.

Throughout his career, Jaap has undertaken key projects such as:

• Project Director in Indonesia (2024-Present): Leading the implementation of multiple vaccine facilities and overseeing cross-contamination avoidance strategies.

• Interim Head of Quality Assurance for Dutch Veterinary Manufacturers (2017-2022): Upgrading quality systems and regaining GMP licenses after disapproval by authorities.

• Vice President Corporate Quality Assurance at Panacea Biotec in India (2011-2019): Successfully leading the company to re-qualification by WHO after de-listing.

• Manufacturing Manager at Bilthoven Biologicals (2014-2015): Managing aseptic formulation and filling departments during a significant increase in manufacturing demands.

• GMP Lead Auditor for Novartis (2010-2013): Conducting cGMP-based audits worldwide to ensure compliance and quality standards.

Jaap's skills encompass GMP compliance, vaccines, WHO and EU GMP standards, crisis management, quality culture development, project management, and team leadership. His global experience includes significant stints in the United States, India, Austria, and various projects across Europe and Asia. Jaap continues to influence the pharmaceutical industry through his commitment to quality assurance and operational excellence.

Eric van Wensveen is a seasoned professional with over four decades of experience in the pharmaceutical industry, specializing in quality management and assurance. Since July 2022, he has been the Owner and Director of Quality Management at adQvice, where he also serves as a Qualified Person (QP) and Responsible Person (RP). In this role, Eric provides expert consultation on FDA Good Manufacturing Practices (GMP), validation processes, quality assurance, research and development, and various other aspects critical to the pharmaceutical sector.

Prior to founding adQvice, Eric held significant positions at Curium Pharma. From October 2021 to October 2022, he served as a Senior Advisor, and from 2017 to October 2021, he was the Director of Quality Assurance and a Qualified Person at Curium Netherlands BV in Petten. There, he managed a quality department comprising approximately 65 employees, overseeing quality control, microbiology, certification and release, validation, and quality systems. Under his leadership, Curium Netherlands BV expanded its export footprint across Europe, the Middle East, Far East, Africa, the USA, Latin America, and Australia.

Eric's extensive experience also includes a 14-year tenure at Mallinckrodt Pharmaceuticals as the Site Manager for Quality and a Qualified Person. He was responsible for a quality department of 55 employees, focusing on critical areas such as quality control, microbiology, release processes, validation, and quality systems. Earlier in his career, he served as a Senior Project Leader in R&D at Mallinckrodt Medical BV, leading pharmaceutical projects and managing R&D and QC laboratories.

His career began as a Lab Technician in Research and Development at Mallinckrodt Medical BV and Energie Onderzoek Centrum Nederland (ECN), where he gained foundational experience in laboratory skills, environmental chemistry, and analytical method development.

Eric is highly skilled in FDA GMP, validation, quality assurance, GMP, aseptic processing, change control, GxP, quality improvement, quality control, analytical chemistry, CAPA, and various other competencies essential to pharmaceutical quality management. He holds expertise in team leadership, project management, training and development, and auditing.

Joris Lieverse is a dedicated professional in the field of pharmacy and pharmaceutical sciences. Since December 2022, he has been pursuing a PhD at Amsterdam UMC, focusing on advancing knowledge in his area of expertise.

Prior to his doctoral studies, Joris worked as a GMP Consultant and QA Specialist at PCS - Pharmaceutical Consultancy Services from May 2022 to November 2022. In this role, he contributed to Good Manufacturing Practice (GMP) consultancy, training, audits, and software solutions, enhancing quality assurance processes within the pharmaceutical industry.

From October 2019 to April 2022, he served as a PharmD and Project Leader at HagaZiekenhuis van Den Haag. During this time, Joris was involved in various projects that improved clinical pharmacy services and patient care.

Joris gained substantial experience during his internships at several prestigious institutions. In 2019, he completed his final master's internship in clinical pharmacy at Radboudumc in Nijmegen. Earlier, from November 2018 to December 2018, he was a research intern at UMC Utrecht. There, he was responsible for the validation and evaluation of InsightRX, a pharmacokinetic software platform used for therapeutic drug monitoring and individualized drug dosing regimens based on PK/PD modeling. His work focused on processing and interpreting data for anti-thymocyte globulin (ATG) and fludarabine used in conditioning regimens prior to hematopoietic cell transplantation.

Between February 2018 and July 2018, Joris conducted his master's thesis research at the Karolinska Institutet in Stockholm, Sweden. Working in the Mast Cell Biology Group of Professor Gunnar Nilsson, he investigated the role of Wnt signaling in mast cells related to asthma developments. His thesis concluded that Wnt-3a stimulation significantly induced gene expression for chemokine CXCL8 and increased IL-8 protein concentrations in certain cell types.

From November 2017 to January 2018, he interned at Meander Medisch Centrum in Amersfoort. This internship provided him with insights into clinical practice areas such as pharmacovigilance, therapeutic drug monitoring, antimicrobial stewardship, GMP, quality management systems, and medication reviews.

Earlier in his career, from December 2014 to August 2015, Joris interned at Micreos Human Health, a biotechnology company developing targeted antibacterial products based on endolysin technology. His bachelor's thesis explored the future role of the endolysin Staphefekt™ in burn wound infection control, highlighting its potential in preventing infections in burn wounds.

Joris's academic and professional journey reflects his commitment to advancing pharmaceutical sciences and improving patient outcomes through research, clinical practice, and quality assurance.