Intro to Quality by Design and 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.

Audience

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.

Prerequisites:

None

8 Hours

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Contact Information

Email
paulette@pyyoungassociates.com

Phone
1 (650) 967-2700

Address
P.O. Box 2103
Sunnyvale, CA 94087-0103

Course Objectives

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.

Course Outline:

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
Market understanding
Target, Product
Profile, Quality
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)