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
| 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 |
| 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 |
Benefits of the Quality by Design Curriculum
Intro to Quality by Design and Critical Quality Attribute selection 1 day classes demonstrate some of the key tools and ideas of QbD without software.
The balance of the curriculum provides all the tools/software and methods to develop a drug and file it with the FDA/EMA and CFDA.
- Formulation
- How to perform formulation risk assessments
- How to design formulation materials selection and screening
- How to design formulation characterization studies
- How to map out the formulation design space and edge of failure per ICH Q8
- How to characterize, model dissolution and establish tolerance intervals
- How to model accelerated and long term stability and drug expiry
- Analytical Methods and Bioassays
- How to perform analytical method risk assessments
- How to design analytical reagent selection and screening
- How to design analytical method robustness studies
- How to map out the analytical method design space
- How to qualify and or validate an analytical method
- Hot to establish expiry limits for lab reagents and standards
- How to control a method using a standard and SPC
- Process Development
- How to perform process risk assessments
- How to design process materials selection and screening
- How to design process characterization studies
- How to map out the process design space and NOR and PAR limits
- How to select critical process parameters and material attributes
- Scale up modeling and model calibration
- Analysis and reporting of process validation
- How set up process controls using the design space and SPC/PAT
- QC/QA and Regulatory
- How to perform risks assessments from the QTTP and CQAs to all analytical methods and unit operations
- How to file and report CQAs
- How to set specification limits for all CQAs and IPCs
- How to evaluate comparability and equivalence
