On this episode of the podcast, I was joined by Michelle Lott of Lean RAQA. Michelle and I discuss:
Key Topics
- 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.
