Introduction to Quality by Design & Critical Quality Attributes

Course Description

Foundations of Quality by Design are discussed, and methods for generation of Target Product Profile and Critical Quality Attributes are presented. This course requires 8 hours of instruction.


This course is recommended for all managers, directors, scientists, business professionals and engineers who actively work on all aspects of the Biopharmaceuticals, Pharmaceutical and Medical Device development, marketing and manufacturing operations.


There are no prerequisites for this course.

Course Objectives

As a result of the course the participant will be able to:

  1. Explain how Quality by Design impacts product development and submissions.
  2. Understand how line of sight of critical drug attributes throughout the development process.
  3. Define and flow down Critical Quality Attributes in product development.
  4. Link CQAs to risk assessment and development priorities.

Detailed Course Outline

Section I: Introduction to Quality by Design

FDA and EU guidance on QbD
Purpose and opportunity
QbD benefits and impact on FDA submissions
Systematic product development

Section II: Systematic Product Development

Market understanding
Target Product Profile
Quality Target Product Profile
Critical Quality Attribute (CQAs) definition
CQA flow down and line of sight

Section III: QbD Implications to Analytical Method and Process Development

Method development implications
Process development implications
QbD and Validation (Lifecycle Approach)