Implementation of a Compliant Quality Management System From Inception  

This project took place in a Biotech startup. Together with the Company’s team, a Quality Management System (QMS), compliant with GMP and GDP, was implemented in 15 months and successfully accepted by the responsible Health Authorities. The QMS covered manufacturing, QC, QA, and logistics activities. 

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Analysis of Risks Related to Human Factors in Cell Therapy Manufacturing 

In the early phases of Cell Therapy clinical trials, the majority of the realized operations depends on human activities. To control the related risk, we performed a risk analysis within a European company active in the development and production of Cell Therapy items. Our analysis was performed using the Bowtie model and an audit of the safety barriers in place. The deliverables of the project were a portfolio of mitigation measures to prevent human errors.  

  

Root Cause Analysis Training 

​We trained American and European Pharmacovigilance (PV) employees of a Global Biopharmaceutical Company on Root Cause Analysis methods. Practical PV-related exercises were developed in order to coach staff on the handling of deviations and audit findings. 

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Implementation of a Quality Check in The Packaging Line 

A daily quality control check was implemented in a company producing chemical drugs for Belgium and for exportation. Thanks to this additional barrier, three potential batch recalls were prevented.  

 

Our Experience in Numbers 

     50 GxP audits performed (GMP, GDP, GPvP) 

     165 ATMP batches released 

     5 Successful inspections hosted  

     2 Quality Management System designs for Biotech companies 

     1 Quality & Regulatory synergy group created 

     Involved in the launch of 4 new Investigational Medicinal Products (IMPs) 

     Member of 6 Professional Associations 

     3 Languages: English, French, Dutch