Quality by Design Training Course in the United States

Implementing the Quality by Design (QbD) principles in manufacturing has resulted in reduced operating costs, highly efficient manufacturing processes and better positioning companies to meet increasing regulatory expectations. The Quality by Design course will teach participants to prioritize process parameters for screening designs, design robust processes using statistical design of experiments (DoE), bridge the bench and the commercial design spaces using mixing and scale-up calculations, quantify process risk, select suitable process analytical technology tools (PAT) and more

After completing your Quality by Design training, you will gain a basic understanding of:

• The origins and need for QbD for pharmaceutical products
• The objectives for current QbD practices
• The overall logic and flow of the QbD development process, which includes the use and application of the various tools
• Development and use of Quality Target Product Profiles (QTPPs)
• Definition and verification of Critical Quality Attributes (CQAs), Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs)
• Facets of statistical design of experiments (DOEs),
• Design Space and its application in process control, lifecycle management, understanding design space limits.
• Development and optimization of process control strategies, which includes real-time release testing.

Job roles that can ideally take up Quality by Design Course, but are not limited to:

• Distribution Manager
• Production Managers
• Engineering Team
• Technical Staff
• Quality Assurance
• Regulatory and Other Management positions who are directly or indirectly involved in manufacturing processes

There are no pre-requisite criteria to take up Quality by Design Training.