Articles & Publications
Articles and Publications
The following articles and publications written by Dr. Tom Little have been published by leading industry and scientific journals and publications. This material has been used by Fortune 500 to successfully achieve desired results. Each article below is completely free to view and download.

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Identifying and Controlling CPPs and CMAs
Published by BioPharm International

Process Characterization Essentials Part I: Process Understanding and Health Authorities Guidance
Published by BioPharm International

Establishing Acceptance Criteria for Analytical Methods
Published by BioPharm International

Essentials in Tolerance Design and Setting Specification Limits
Published by BioPharm International

Out of Trend Identification and Removal in Stability Modelling and Regression Analysis
Published by BioPharm International

Robust Optimization, Simulation and Effective Design Space
Published by BioPharm International

Method Validation Essentials, Limit of Blank, Limit of Detection and Limit of Quantitation
Published by BioPharm International

Equivalence Testing for Comparability
Published by BioPharm International

QbD Approach to Assay Development and Method Validation
Published by BioProcess International

Developing Representative Sampling Plans for Development, Problem Solving and Validation
Published by BioPharm International

Evaluating Design Margin, Edge of Failure, and Process Capability
Published by BioPharm International

Quality Risk Management for Drug Products and Drug Substances
Published by BioProcess International

Multifactor Non-linear Modeling for Accelerated Stability Analysis and Prediction
Published by Pharmaceutical Technology

Accelerated Stability Modeling
Published by BioPharm International

Design of Experiments for Analytical Method Development and Validation
Published by BioPharm International

Essentials in Quality by Design
Published by BioProcess International

Understanding and Modeling Product and Process Variation
Published by BioPharm International

Assay Development and Method Validation Essentials
Published by BioPharm International

Using a Systematic Approach for Selecting Critical Process Parameters for Process Control
Published by BioPharm International

Essentials in Establishing and Using a Product or Process Design Space
Published by BioPharm International

Essentials in Stability Analysis and Expiry Determination
Published by BioPharm International

Method Validation by Design to Support Formulation Development
Published by Pharmaceutical Technology (PharmTech)

Essentials in Quality Risk Management
Published by BioPharm International

Ten Requirements for Effective Process Control
Published by ASQ, Quality Progress

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