Wendy 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 enhanced approaches to biopharmaceutical drug development, and implementation of the process validation lifecycle. She believes that knowledge management is the foundation for successful lifecycle management, and is passionate about transforming pharmaceutical quality systems to align with concepts outlined in ICH Q10. Wendy is on the faculty at Northwestern University and teaches graduate courses in drug development and regulatory affairs. She is active in a number of industry associations, and is an ASQ Certified Manager of Quality / Operational Excellence. She holds a Regulatory Affairs Certification from the Regulatory Affairs Professional Society.