What is the QA RA Mindset with Michelle Lott
Michelle Lott and I are discussing our Experience in the Quality and Regulatory affairs area. We will help you define what is compliance and how we think it should be applied. Michelle had also some good and bad experiences that she is sharing with us.
Who is Michelle Lott?
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.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companIES and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Links from the Video
- Linkedin Michelle Lott: https://www.linkedin.com/in/michellelottraqa/
- Lean RAQA Website: https://leanraqa.com/
- Lean RAQA Today Podcast: https://soundcloud.com/raqatoday
- Blog Post “What is Quality?”: https://easymedicaldevice.com/what-is-quality/