The Five Stages of Regulatory Grief
Meet your grief counselor, Michelle Lott, RACHi, I'm Michelle, thank you for visiting my site today. You probably wouldn't be here if you didn't need some kind of regulatory help.
- FDA Advisor: Serving a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP). Reviewing feasibility and reasonableness, recommending proposed good manufacturing practice regulations in manufacturing, packing, storing, and installing devices.
- Founder and principal: Lean RAQA Systems (since 2010). By 2018, supported more than 100 companies with services including regulatory strategy, regulatory submissions, quality systems compliance, due diligence, and a considerable range of technical support services.
- Education: Northwestern's Kellogg School of Management (Regulatory Affairs Professionals Society certification); Troy State University (BS, Chemistry)
- Interesting fact: Formerly an expert witness in forensic toxicology at the Mississippi Crime Laboratory.
- Weakness: Anything barbecued. And tequila. Lots of tequila.
- Particularly good at: Supporting startups' first quality system and submission. Remediation services for large companies, too.