Waunetka A. Clark is a Principal Quality Engineer in the Global Pharmaceutical Operations Division of Abbott Laboratories. She has 20 years of software QA experience in the pharmaceutical industry within manufacturing automation systems and computer IT systems. For the past 2 years, she has provided project management expertise for projects within the Global Quality Systems (GQS) group. Prior to her current assignment, Waunetka provided significant contributions to establish and pilot the Risk Based Commissioning and Qualification program at Abbott Lab for manufacturing sites where a science and risk based approach to decision making is used to determine the level of qualification for equipment, facility, and utility systems. Waunetka managed the first pilot of this program. She also has a number of years experience as a project manager developing business system software for regulatory submissions, sales force automation, and manufacturing execution. Waunetka holds a B.S. degree in Electrical Engineering from Tuskegee University is PMP certified. She is also Green belt certified in applying Lean Six Sigma tools and methodology. Professional affiliations include GAMP Steering Team member, JETT consortium SIG member, and Project Management Institute (PMI) member.