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Kirsten Lingbeek-Brummelhuis

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Kirsten Lingbeek-Brummelhuis
MSc, pharmacist COO

Kirsten Lingbeek is a pharmacist by education and is leading the Compliance and Validation department of Xendo since December 2012.  She has started her career in the hospital pharmacy, after which she joint Solvay Pharmaceuticals (today Abbott Healthcare) as production Pharmacist and team lead for Clinical Trial Materials. She was responsible for the manufacturing of drug product and the packaging and labeling of investigational medicinal products (IMP). During that period, she was a registered Qualified Person for the release of IMPs. In 2006 she became team lead for Clinical Supply Management and acted ad interim as product development manager for a phase III program. She has set-up, led and developed a global department, responsible for the complete Clinical Supply Chain: drug substance, drug product, packaging and labeling of Investigational Product (IP) and the IP logistics to the sites until destruction. In 2010 she joint Genzyme Europe as Director Clinical Pharmacy Research Services, where she was responsible for the strategic leadership of the EU Clinical Pharmacy team, which included clinical supply management and clinical site pharmacy management. Next to her expertise in product development (R&D), she also has a broad experience in outsourcing, set-up lean processes across divisions, departments and sites, and change and transition management.

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Compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP) and ISO standards is compulsory in the pharmaceutical, medical device and healthcare fields. Besides being compliant, the processes in question should also be constantly upgraded or enhanced, thus reducing waste, lowering costs, saving time and increasing compliance at the same time. As a reliable partner, we help you assess your compliance level and we provide you with solutions for the implementation of improvement projects based on the Lean Six Sigma principles.

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Quality Assurance & Risk Management

Quality Assurance means guaranteeing quality throughout your organisation. Besides providing you with services that increase the compliance and efficiency of your organisation, we also provide audits, mock inspections and Gap analyses and assist you with management reviews, change management (deviations, CAPAs & complaint handling), internal audits, supplier selection, and the implementation of regulatory updates. From the perspective of GMP and ISO standards, Risk Management is technically not new, but its impact is increasing all the time. In order to prepare for the current requirements, we try to optimise Risk Management in terms of the quality, safety, and efficacy in your Quality Management Systems.

For deviations, CAPAs and complaint handling, we have our special Lean Backlog Reduction programme, which ensures that the backlog is removed and that a system is put in place to maintain control and avoid a new backlog.

Lean Six Sigma

Our organisation applies the Lean Six Sigma principles in the projects in which we participate in order to optimise results and deliver robust and optimal solutions. Originally part of Toyota’s Just-in-time Manufacturing, this strategy is now also widely implemented in biotech, pharmaceutical, and medical device companies in which waste reduction, time-saving and process improvement can make a significant difference not just to the manufacturing processes but also to Quality Assurance and Laboratories.

In order to cater to the diversity of businesses in these fields, we help companies by managing improvement projects and providing training and consultancy (which are supplied by our experienced Black Belt and/or Green Belt consultants). 

Xendo offers Yellow and Green Belt training in cooperation with Biotech Training Facility in Leiden. This allows us to offer belt-training in a real-life pharmaceutical production setting. It is pragmatic, like the lean philosophy. And the trainers have a thorough understanding of and experience with both Lean Six Sigma and today’s life sciences.  For more information take a look at the Yellow Belt or the Green Belt training.

Distribution (GDP & Responsible Person)

Good Distribution Practices are essential parts of the quality systems of the manufacturers and distributors of medicines and medical devices. Globalisation and the increasing complexity of the supply chain have led to a tightening of regulations. To ensure that your valuable product is shipped and stored properly and that patients can rely on a safe and effective product, our GDP specialists use their extensive knowledge of GDP theory and their hands-on experience to help you optimise your distribution processes and obtain a wholesaler’s license. They ensure that you are always in control of your supply chain; our services include the adoption of the role of the Responsible Person.

Manufacturing (GMP & Qualified Person)

You could say that GMP is in our genes. Many of our consultants are industry pharmacists and specialists who are familiar with the ins and outs of the applicable quality standards and can help you design or adapt your product’s quality and safety processes in order to minimise the risks involved in (bio)pharmaceutical production. We cover all aspects of the manufacturing process, from the starting materials and equipment to the training of staff and the release of your finished products by one of our Qualified Persons.

  • Audits & GxP Inspection
  • Inspection preparedness
  • Quality Management Systems (GxP, ISO)
  • Training
  • Documentation Systems
  • Hands-on support for complaint handling, deviations, CAPAs
  • Qualified Person (QP)
  • Responsible Person (wholesalers license) – RP
  • Interim Management
  • QA Management
  • QC Management

Quality Management Systems & Quality Control

Our Quality specialists help you set up, design and/or improve your Quality Management System, providing your organisation with a solid structure in terms of procedures, processes and resources and allowing you to streamline manufacturing and cost-effectively mitigate potential quality issues. They can also effectively integrate the system into a closed-loop quality process and pro-actively monitor any risk that remains after mitigation across the manufacturing chain. Their extensive experience enables them to identify and prevent issues that might otherwise later require a significant investment in either hours or capital.

Quality Control plays a pivotal role in ensuring that the product complies with the specifications in the marketing authorisation / technical documentation. In addition, the testing of starting materials and in-process controls is an important task of Quality Control. For aseptic production processes, environmental monitoring is required to prove that cleanrooms, including the people and processes concerned, are functioning properly. Our consultants have wide-ranging hands-on experience with quality control activities and can assist you in a variety of ways.

GxP & ISO13485 Compliance

Biotech, pharmaceutical and medical device companies operate in a regulated environment and they must all comply with stricter regulations and requirements. The complexity often increases due to globalisation and compliance with all the applicable GxP and / or ISO requirements can become a time-consuming and costly task. Our consultants have the experience and knowledge to help you achieve compliance or determine where potential GAPs might be located:

  • GMP – Good Manufacturing Practice
  • GDP
  • GLP
  • GCP
  • GAMP
  • ISO 14385
  • ISO 14971
  • ISO 62304

Strategy

Given that the Product Quality Review or the Annual Product Review are valuable components of your product quality management process, the Management Review is the ideal mechanism for assuring that senior management makes decisions and plans based on factual and up-to-date information about the output of the quality management system. Because the Management Review has been included in the ISO 9001-based quality systems for a long time, the requirement for a regular Management Review to identify opportunities to improve products, processes and the quality system itself is quite new in the EU GMP. Xendo’s QA and lean professionals are experienced in setting up Management Review cycles with informative quality metrics, scientific sound data analysis and a realistic output.