Ms. Yonker earned a B.A in Business and advanced studies in management from SDSU and has over twenty years in the Pharmaceutical, Biotechnology and Medical Device industries. She is a senior consultant for Expemplar Compliance and has held previous positions at Johnson & Johnson - Alza Corp, Novartis Vaccines & Diagnostics as well as several consulting engineering groups. Her experience includes project management, operations, validation and quality. She has expertise in aseptic processing, biological containment, biotechnology, oral solid dose, drug/device combination products, and in vitro diagnostics. Recent projects have focused on implementation of Process Validation Lifecycle for legacy products and project management and oversight for the manufacturing of clinical trials materials. She has been actively involved with ISPE for over 10 years. Her ISPE activities have included presentations at multiple chapter events, training sessions and Annual meetings and serving on the C&Q CoP Steering Committee.