Quality by Design (QbD), PAT and Design of Experiments (DoE)

• Explain QbD principles and regulatory basis (ICH guidelines)

• Define relationships between CQAs and CPPs

• Understand Quality Risk Management (QRM) in control strategy design

• Identify key QbD tools (PAT, DoE)

• Apply QbD to process understanding and lifecycle management

Staff involved in R&D, process development, validation, and quality assurance activities.
 

Good understanding of GMP basics and validation practices (annex 15)

• Fundamentals of the QbD approach

  • QbD principles and regulatory framework (ICH guidelines)

  • From fixed processes to science- and risk-based approaches

  • Role of Quality Risk Management (QRM) in control strategy development

• QbD implementation

  • Key tools for QbD implementation

  • Statistical and analytical tools for design space development

  • Role of knowledge management across the product lifecycle

  • Methods to support process understanding and robustness

• Product and process understanding

  • Identification of Critical Quality Attributes (CQAs)

  • Identification of Critical Process Parameters (CPPs)

  • Link between product quality and process parameters

• Design of Experiments (DoE) and PAT

  • Principles and applications of DoE

  • Introduction to Process Analytical Technology (PAT)

  • Use of DoE and PAT for process monitoring and control