Ms. Karen A. Welch is Director of Business Excellence, Strategic Projects at Abbott. She has over 15 years of experience working with Regulated industry - Pharmaceutical, Diagnostics, and Medical Device - with a primary focus on Quality Improvement and Quality Systems. Throughout her career she has actively practiced Six Sigma, Design of Experiments, and Continuous Improvement techniques to help design quality into the product as opposed to "testing" it in at the end.

Prior to this, she was Founding Partner of the Center for Risk-based Strategies, Inc.where she taught and consulted in a variety of ways applying established improvement methodologies to comply with regulation. She helped define a science-based approach to process validation which uses design of Experiment (DOE) and ties specifications to the customer by "transfer functions". She played a key role in teaching Six Sigma and Lean techniques at various GlaxoSmithKline (GSK) sites worldwide. This project was fundamental in challenging current ways of working and gaining improvements in quality, cycle time and productivity, as well as improving delivery performance.