Michelle Lott is the Founder and Principal of leanRAQA. She’s supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services – and grief counseling, because dealing with regulators can be emotionally draining. Her clients delegate RA and QA functions to her so that they can focus on winning in the marketplace. Ms. Lott served a four-year term on FDA’s Device Good Manufacturing Practices Advisory Committee (DGMP), holds a BS in Chemistry from Troy State University and is a Certified Executive Leader in Regulatory Affairs from RAPS and Kellogg University.
