Lori Richter is pursuing her PhD under the supervision of Dr. Anne Greene and working with the Pharmaceutical Regulatory Science Team (PRST), a research team based at the Technological University Dublin (TU Dublin) in Ireland. She is also a Senior Consultant at ValSource. Lori holds a Bachelor of Science in Microbiology and over 20 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management (QRM), Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. She has developed many QRM training modules and delivered training to both Health Authorities and industry teams. Lori is a member of the PDA Regulatory and Quality Advisory Board (RAQAB) and PDA Europe Interest Group on GxP Training. She was an author for PDA TR 54-5, Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems and is an Instructor for the PDA Quality Risk Management Certificate Program. She is the West Coast Chapter PDA President-elect.