Wendy Zwolenski Lambert has over two decades of diverse experience in the pharmaceutical and medical device industries. Her experience includes roles in analytical chemistry, process and quality engineering, quality management and regulatory affairs. Her current role is focused on process validation lifecycle for both new and establshed products. She is active in a number of industry associations, and participated in the creation of the A-mAb case study. Wendy is an ASQ Certified Manager of Quality / Operational Excellence and holds a Regulatory Affairs Certification from the Regulatory Affairs Professional Society.