Training Courses and Workshops
Medical Devices, IVD & Pharmaceuticals
Practice-oriented training in risk management, statistical methods, robust product development, and process optimization. We combine regulatory requirements with practical applications in research and development, manufacturing, and quality assurance.
Our Medical Device Engineering training focuses on risk management and robust product development. Topics include ISO 14971, Design FMEA, Usability Engineering, Design for Six Sigma, Reliability Engineering, and Design Verification & Validation. These practice-oriented courses are designed for professionals in Research & Development, Design Engineering, Quality Engineering, and Regulatory Affairs.
Our IVD Development & Analytical Performance training covers analytical performance evaluation and statistical methods for in vitro diagnostics. Key topics include EU IVDR, method comparison, measurement uncertainty, Design of Experiments (DoE), and stability studies. The courses are tailored to professionals in IVD Development, Analytical R&D, and Quality Control.
Our Pharmaceutical Quality & Process Engineering training focuses on quality risk management, statistical methods, and process optimization. Topics include ICH Q9, Quality by Design (QbD), Design of Experiments (DoE), Process Validation, Statistical Process Control (SPC), FMEA, Root Cause Analysis, and Corrective and Preventive Actions (CAPA). These courses are designed for professionals in Process Development, Manufacturing, Quality Assurance, and Quality Control.