031 - "The Five Stages Of Regulatory Grief" with Michelle Lott

On this episode of the podcast, I was joined by Michelle Lott of Lean RAQA. Michelle and I discuss: - Her background starting at a manufacturing site and moving into QA and RA - Being Outspoken and Honest  - What she's observed between large and small organizations - Her Experience being an industry rep on the FDA Device GMP Advisory Committee - Regulations vs. Guidance's and how they come about - The 5 stages of regulatory grief  - QMSR Harmonization - Audit Preparation (See Michelle's Blog @ LeanRAQA.com) (See Michelle's Podcast @ Spotify Link) ------------------------------------------------------ Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries. She has a weakness for tequila and anything barbecued.