Design of Experiments
Actively manipulate factors according to a pre-specified design to quickly and easily gain useful, new understanding.
- QbD: Using DOE to Increase Knowledge of the Process and Design Space
- Optimal Experimental Plan: DOE experts Peter Goos and Bradley Jones
Statistical Process Control
Separate common and special causes to assist your process analysis efforts, including problem investigation, out-of-control conditions and ongoing monitoring for stability.
- Using Statistical Process Controls to Improve and Monitor your Process
- Multivariate Statistical Process Control
- Free Online Course: Quality Module (Includes Statistical Process Control)
Stability and Shelf Life Analysis
Assess poolability of batches, establish expiration dating, and easily calculate confidence limits and crossing times -- all in adherence to ICH guidelines.
- Pharmaceutical Product Stability
- Stability Analysis Made Easier
- JMP Tools for Pharmaceutical Companies: Stability Analysis and Assessing Consistency in Manufacturing
Quality by Design (QbD) & Robust Process Optimization
Find the ‘sweet spot’ in the design where performance is minimally sensitive to variation for all critical quality attribute (CQA) goals in your process.
- Optimizing Pharmaceutical Production Processes Using Quality by Design Methods
- Pharmaceutical Quality by Design Using JMP: Solving Product Development and Manufacturing Problems
- Quality by Design for Medical Device Engineers
- Improving Product Reliability with Quality by Design
- Unlock the Hidden Value of QbD with the Prediction Profiler Simulator
- Improving Processes with Statistical Models
- Big Data, Pharma 4.0 and Process Modeling
Methods to Develop, Compare and Transfer within the Pharmaceutical Industry.
Other Related Resources
- Julia O'Neill on Statistical Thinking and Drug Development
- Operational Excellence in Pharmaceutical Manufacturing
- Saving Big Money in Pharmaceutical Manufacturing with Data Analytics
- Process and Product Understanding are Key to Operational Excellence
- Fantastic Trends in FDA's 483s and How to Find Them
- Working with and Interpreting COVID-19 Data