Quality by Design (QbD) Workshop
With MINI TAB
3 Sessions
Course Description
Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management.
This course introduces the principles, methodology, and tools that allow professionals to design and optimize pharmaceutical products and processes that consistently meet quality standards and regulatory expectations.
Participants will learn how to build a Quality Target Product Profile (QTPP), identify Critical Quality Attributes (CQAs), define Critical Process Parameters (CPPs), and establish an effective Control Strategy that ensures consistent product performance throughout its lifecycle.
This course blends regulatory guidance (ICH Q8-Q11, FDA QbD model) with practical examples of formulation and process optimization.
Who should attend ?
Quality Assurance & Quality Control Professionals
R&D Scientists and Formulation Specialists
Process Engineers and Validation Experts
Six Sigma and Continuous Improvement Practitioners
Production Supervisors and Managers
Regulatory and Technical Affairs Personnel
Course Topics:
Pharmaceutical Development
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Historical background, ICH Q8(R2), and FDA guidance
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Principles of “design space” and “control strategy”
Building a Quality Target Product Profile (QTPP)
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Linking patient needs to product performance
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Identifying product-specific CQAs
Risk Management in Pharmaceutical Development
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Tools: FMEA, Ishikawa, and Pareto analysis
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Linking risk ranking to formulation variables
Design of Experiments (DoE) for QbD
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Screening vs. optimization designs
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Factorial and response surface methodologies
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Statistical interpretation (ANOVA, regression, model validation)
Formulation and Process Understanding
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Linking raw material attributes to product CQAs
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Process mapping and critical process parameter identification
Control Strategy and Lifecycle Management
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Establishing process monitoring systems
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Continual improvement and post-approval changes
Regulatory Submissions and QbD Integration
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CTD Module 3 (Quality 3.2.P.2) documentation
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Example of QbD implementation for an ANDA (IR tablet)
Software & Statistical Tools
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Minitab for practical study planning
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Data analysis workflows and visualization of design space
Number of Sessions :
3 sessions
SPEAKER
Dr. Akram Bashir
Branch Manager of Nawah Scientific and the formulation Lab.
Specifications for Quality by Design (QbD) Workshop
| Attendance type | In-person/ Virtual |
| Minimum Experience | 1 |
| Number of Sessions | 4 |
| Accreditation | VALOR |
