Intro 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 is recommended for all managers, directors, scientists, business professionals and engineers who actively work on any aspects of the Biopharmaceuticals, Pharmaceutical and Medical Device development, marketing, and manufacturing operations.
1 (650) 967-2700
P.O. Box 2103
Sunnyvale, CA 94087-0103
Upon completion of the course the participants will be able to:
- Explain how Quality by Design impacts product development and submissions.
- Understand how line of sight of critical drug attributes throughout the development process.
- Define and flow down Critical Quality Attributes in product development • Link CQAs to risk assessment and development priorities.
Introduction to Quality by Design
FDA and EU guidance on QbD
Purpose and opportunity
QbD benefits and impact on FDA submissions
Systematic product development
Systematic Product Development
Critical Quality Attribute (CQAs) definition
CQA flow down and line of sight
QbD Implications to Analytical Method and Process Development
Method development implications
Process development implications
QbD and Validation (Lifecycle Approach)