Introduction to Quality by Design and Critical Quality Attributes

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.

Course Objectives

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.

Attendees

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.

Prerequisites

There are no prerequisites for this course.

Section 1: 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 2: 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 3: QbD Implications to Analytical Method and Process Development

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