SMIMA1091U Quality by Design (QbD) in Pharmaceutical Development

Quality by Design (QbD) lies at the core of modern pharmaceutical development, offering a scientifically sound and cost-efficient pathway to delivering high-quality medicines to patients. Global regulatory authorities — including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) — now emphasize QbD principles as an integral part of regulatory submissions. As a result, QbD has become a cornerstone of streamlined, risk-based drug development and manufacturing.

This course provides an in-depth exploration of QbD principles, spanning quality risk management, formal experimental design, and process analytical technology (PAT). Guided by leading experts from industry, academia, and regulatory agencies, participants will gain both a conceptual understanding and practical insight into how QbD strategies can be effectively implemented within their organizations.

Through interactive lectures and practical demonstrations, the course equips participants with the skills to apply QbD methodologies across the product lifecycle — from design to commercialization.

Key Learning Topics:

• Fundamentals of risk analysis and quality management

• Developing the Quality Target Product Profile (QTPP)

• Identifying Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)

• Applying Design of Experiments (DoE): from basic screening to advanced designs

• Understanding Process Analytical Technologies (PAT): chemometrics, process monitoring, and measurement techniques

• Navigating the risk-based regulatory framework for QbD implementation

Who Should Attend:
This course is designed for professionals and lifelong learners in the pharmaceutical and biopharmaceutical sectors - including, e.g., formulation scientists, process engineers, regulatory affairs specialists, and quality professionals - who wish to enhance their expertise in QbD principles and practical applications.