Design Expert - Quality by Design
Product information "Design Expert - Quality by Design"
Course: Quality by Design (QbD) โ Statistical Experimental Design for Pharmaceutical Processes
Quality by Design (QbD) is the FDA-recommended method for developing and optimizing pharmaceutical products and processes. The central idea is to define factor spaces within which consistent product quality is ensured. Once a design space is approved by regulatory authorities, the process can be adjusted within these limits without requiring re-approval.
This methodology provides new flexibility in the production of pharmaceutical products and medical devices, reducing regulatory hurdles.
What You Will Learn in This Course:
๐ Fundamentals of Quality by Design (QbD) & Design of Experiments (DoE)
๐ Statistical Tools: Hypothesis Testing & Regression Analysis
๐ Screening Designs: Efficiently Identifying Key Factors
๐ Response Surface Designs: Defining and Optimizing Design Spaces
๐ Validation of Design Spaces for Regulatory Approval
๐ Practical Implementation with Design-Expertยฎ Software
The course will follow a complete QbD cycle using FDA examples and statistically model it with Design-Expertยฎ software.
Requirements:
๐ Basic knowledge of Design-Expertยฎ is beneficial.
๐ Knowledge of regression analysis and hypothesis testing is helpful but not required.
๐ Course Duration: 3 Days
๐น Sign up now and optimize your pharmaceutical development!