About Quality by Design Consulting

The “Quality by Design” (QbD) initiative from the FDA provides guidance on pharmaceutical development to facilitate design of products and processes that maximize the product’s efficacy and safety profile while enhancing product manufacturability and control.

Fundamental to this approach is an understanding of the relationship between the quality attributes of the product and their impact on safety and efficacy. This website provides the curriculum, consulting resources, tools, templates, and white papers on specific topics for Quality by Design application support and assistance.

Thomas A. Little Consulting (TLC) is an internationally recognized scientific and engineering consulting organization with a proven record for achieving results. We have extensive experience in biologics, small molecule and vaccine development and validation. TLC also has an extensive QbD SAS/JMP based modern drug development curriculum for product and process development, quality risk management, data analysis, characterization, optimization, life cycle management and control. We are also a strategic partner of SAS/JMP.

Please explore our Course Curriculum for on-site or web based training and Consulting Services to discover which options work best for you and your company.

Download the QbD Training Curriculum

Biotech and Pharma, QbD & Product Development Curriculum
Days Product Development and QbD Curriculum Process Sciences Analytical Sciences Quality Assurance Formulation
*Core Courses are Highlighted in Green
1 Introduction to QbD and Critical Quality Attributes
3 Statistical Methods and Data Analysis
2 Design of Experiments
1 Mixture DOE
2 Analytical Method Development and Validation
2 Quality Risk Management and Risk Assessment
2 Root Cause Analysis and CAPA
2 Robust Optimization, Design Space and Tolerance Design
1 Statistical Methods for Process Validation
1 Stability Analysis
2 Process Control Design using SPC/PAT
1 Nonlinear Modeling (Dose Response, Relative Potency)
20 Total 18 19 14 16
Suggested Course Implementation
Days Suggested Implementation Sessions Purpose of the Course
© 2015 Thomas A. Little Consulting
Session 1
1 Introduction to QbD and Critical Quality Attributes Foundations in Quality by Design, Organizational Alignment and Development Objective Alignment
3 Statistical Methods and Data Analysis General JMP Skills, Data Analysis, Equivalence and Comparability and Model Building
Session 2
2 Quality Risk Management and Risk Assessment Risk Assessments prior to Development and Study Designs
2 Design of Experiments Study Designs and Analysis for Product and Process Development
Session 3
2 Analytical Method Development and Validation Study Designs and Analysis for Robustness, Specificity, Stability, Precision, Accuracy, Linearity, LOB, LOD/LOQ and Range
2 Robust Optimization, Design Space and Tolerance Design Product and Process Optimization, Design Space Generation, Edge of Failure Determination, and PAR and NOR Ranges and Tolerances
Session 4
1 Mixture DOE Formulation Study Designs and Analysis
1 Stability Analysis Determination of Expiry and Rates of Degradation under Ambient, Accelerated and Storage Conditions
2 Process Control Design using SPC/PAT Process Control Design and Associated Adjustment Protocols
Session 5
2 Root Cause Analysis and CAPA Determination of Root Cause and Corrective Actions
2 Nonlinear Modeling (Dose Response, Relative Potency) All Nonlinear Reponses, Potency and Dose Reponses Determination
1 Statistical Methods for Process Validation Statistical basis for lot variation analysis, PQ Study Design and Analysis