What Is the Quality by Design Approach in Pharma?UntitledA Science-Led Way to Build Quality In
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 Cameroon gives your teams a working command of that approach and the tools behind it. The programme is grounded in the ICH guidelines that define modern pharmaceutical development: ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. These are the expectations that regulators such as the FDA and EMA increasingly look for in development and manufacturing submissions. Across one focused day, formulation, process and analytical scientists, quality assurance staff and regulatory affairs professionals learn to apply the Quality Target Product Profile (QTPP), critical quality attributes, risk assessment, Design of Experiments, the design space and the control strategy. It is practical, workplace-ready learning for Cameroon's growing pharmaceutical sector, delivered live online, in the classroom or on site.










