Michelle Lott is founder and principal of Lean RAQA Systems (leanraqa.com) where she has supported more than 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 all those things to her, so they can focus on winning in the marketplace! Michelle served a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP). She holds a BS in Chemistry from Troy State University and an Executive Leadership Certification in Regulatory Affairs from RAPS and Kellogg University.
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