QbD Training: Product and Process Optimization Using DoE

That Center for Professional Innovation and Education (CfPIE) has introduced a new training course, titled QbD: Product and Process Optimization Using Design of Experiments (DoE).

Quality by Design (QbD) means that, starting from the very first development step, products and processes are designed in a way to ensure a high level of quality and reliability. One of the main QbD tools is statistical Design of Experiments (DoE), which enables you to perform the necessary experiments in an efficient and structured way.

This comprehensive three-day course is designed for chemists, engineers, pharmacists and biotechnologists in research, development and production, as well as for laboratory staff involved in the development or optimization of products and processes. It covers active ingredients as well as formulated products and is of interest not only to the pharmaceutical and biotechnological sectors, but also to scientists working in the chemical and cosmetics industry.

Dr. Philippe Solot or Dr. Stefanie Feiler will be one of two industry-active instructors teaching this course in Berlin, Germany and Malvern, Pennsylvania (Philadelphia area).

Topic areas to be discussed include:

• The importance of Quality by Design (QbD) as part of an efficient QA strategy
• DoE vs. one-factor-at-a-time
• The sequential approach of DoE: screening, modelling and optimization – which design in which context?
• Definition of a practical problem as the first step of the application of DoE
• Factor screening and modelling: how to identify the Critical Process Parameters (CPP’s) and Material Attributes (CMA’s) as well as their interactions
• Optimization of a response variable with response surface models
• Graphical visualization and interpretation of the results
• DoE for formulations
• Defining the Design Space
• Robustness issues
• Accounting for real-world challenges: complex restrictions, unsuccessful experiments

Certification Tracks:

(CCCP) Clinical Compliance Certified Professional™

(GRACP) Global Regulatory Affairs Compliance Professional™

(PDCP) Pharmaceutical Development Certified Professional™

Full Course Description, Agenda and Learning Objectives.

As the global leader in technical Life Sciences training, CfPIE offers training and certification programs that improve skills, maintain regulatory compliance, and enhance career opportunities.