Download the full curriculum for Statistical and Analytical courses in PDF format.
Systematic product development, Quality by Design courses, consulting services and analytical training for biotechnology, pharmaceutical and medical device industries. QbD provides guidance to facilitate design of products and processes that maximize the product’s efficacy and safety profile while enhancing product manufacturability and control.
Complete curriculum for new product development, manufacturing and business process performance optimization.
Development tools and templates created by Thomas A. Little Consulting have been used by numerous companies to aid and support various aspects of product development, problem solving, data analysis and risk assessment.
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:
- 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.
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
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)