The Quality by Design Information

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.