Program Overview
This program provides participants with a comprehensive understanding of QbD principles, Design of Experiments (DoE), and their role in enhancing product and process quality. The program focuses on conceptual clarity, real-world case studies, interactive exercises, and actionable insights to address corporate challenges. Participants will learn to implement QbD frameworks, design robust experiments, interpret results effectively, and solve formulation and process optimization issues.
Features
- Understand and apply QbD principles to optimize products and processes.
- Design and implement experiments using full and fractional factorial designs.
- Analyze experimental data, visualize results, and draw actionable conclusions.
- Address formulation and process optimization challenges effectively.
Target audiences
- Professionals in Quality Assurance, R&D, Process Engineering, Manufacturing, and Product Development.
Curriculum
- 7 Sections
- 31 Lessons
- 2 Days
Expand all sectionsCollapse all sections
- Introduction to Quality by Design (QbD)6
- 1.1Definition and importance of QbD in quality assurance.
- 1.2Overview of DoE within the Six Sigma framework.
- 1.3Regulatory requirements and their implications for QbD.
- 1.4Success stories from industries implementing QbD (pharma, automotive, manufacturing).
- 1.5Case Study: Regulatory challenges and how industry leaders navigated them.
- 1.6Group discussion: Participants share challenges in their domains where QbD can add value.
- DoE vs. One-Factor-at-a-Time Approach4
- Strategic Phases of DoE4
- Experimental Design - Full and Fractional Factorials4
- 4.0Full vs. fractional factorial designs and selecting an appropriate design.
- 4.1Common pitfalls in experimental design and how to avoid them.
- 4.2How global organizations solved critical challenges using appropriate factorial designs.
- 4.3Group activity: Build a factorial design for a real-world product issue.
- Analysis of Experimental Results4
- Numerical and Graphical Model Quality Assessment5
- Addressing Formulation Problems4
Instructor
