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)

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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.