What Is Quality by Design and Why It Matters in PharmaUntitledA Science-Based Route to Built-In Quality
Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical product and process 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 Namibia gives formulation scientists, process engineers, analytical scientists and quality professionals the practical tools to apply QbD on real development projects. The course is grounded in the ICH quality framework: ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances, the guidelines that regulators such as the FDA and EMA now expect behind modern submissions. You learn to define the Quality Target Product Profile (QTPP), identify Critical Quality Attributes (CQAs), run risk assessment, design experiments (DoE), map the design space and build a control strategy. For Namibia's growing pharmaceutical, biopharmaceutical and regulated manufacturing base, QbD skills help teams meet NMRC and GMP expectations and reduce costly batch failures. Start your QbD journey with Invensis Learning.










