Kelly Waldron is currently pursuing her PhD in Quality Risk Management from the Dublin Institute of Technology, Ireland. She has over twelve years of experience in various quality functions in the biopharmaceutical industry, with eight years focused on Quality Risk Management. Kelly has authored several industry and academic papers on QRM and is conducting much of her academic research in collaboration with the Parenteral Drug Association (PDA). She is currently a member of the PDA Task Force “QRM in Design, Commissioning, and Qualification.” Kelly holds a BA in Biology from Boston University and an MBA in Pharmaceutical Management from Fairleigh Dickinson University. Kelly may be contacted at School of Chemical and Pharmaceutical Science, Dublin Institute of Technology, Kevin Street, Dublin 8, Ireland, or at 1125 Pleasant View Terrace, Ridgefield, NJ 07933. Phone: 1-508-380-0243 or email email@example.com.