What Is Quality by Design and Why It MattersUntitledA Practical Skill for Costa Rica's Life Sciences Sector
Quality by Design (QbD) Training is a practical, one-day programme that teaches the systematic, science-based approach to building quality into pharmaceutical and biopharmaceutical products from the design stage, rather than testing for it at the end. For professionals in Costa Rica, Quality by Design training in Costa Rica connects directly to one of the world's leading life sciences and medical device manufacturing hubs. The QbD approach is set out in the ICH quality guidelines: ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances, and it is increasingly expected by regulators such as the FDA and EMA. You learn to work with the core QbD tools: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space and the Control Strategy. Whether you work in formulation, process development, analytical science, quality assurance or regulatory affairs, this training gives you methods you can apply to live development projects straight away. Learn Quality by Design with Invensis Learning and turn regulatory expectation into everyday working practice.










