What Is Quality by Design Training?UntitledA Science-Led Route to Better Products
Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical and biopharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. This Quality by Design Training in El Salvador teaches you to apply that approach on real development work, grounded in the ICH Q8(R2) Pharmaceutical Development guideline and the wider ICH quality framework. Over one intensive day you learn the core QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment with FMEA and Ishikawa diagrams, Design of Experiments (DoE), the design space, Process Analytical Technology and the control strategy. The methodology is shaped by ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances, and is increasingly expected by the FDA, the EMA and El Salvador's DNM-aligned laboratories. The training suits formulation and analytical scientists, process engineers, quality assurance staff and regulatory affairs professionals in the country's pharmaceutical, generics and API manufacturers who want to move from empirical trial and error to a structured, defensible way of working. Start building the skill with Invensis Learning.










