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.
As a result of the course the participant will be able to:
FDA and EU guidance on QbD
Purpose and opportunity
QbD benefits and impact on FDA submissions
Systematic product development
Target Product Profile
Quality Target Product Profile
Critical Quality Attribute (CQAs) definition
CQA flow down and line of sight
Method development implications
Process development implications
QbD and Validation (Lifecycle Approach)