What are the TOP 3 FDA inspection issues? скачать в хорошем качестве

What are the TOP 3 FDA inspection issues?

In this episode, Darrin Carlson will explain to us what are the main issues that are discovered during FDA inspections and how to correct them. We will also explain the different between an FDA inspection and a Notified Body audit. So stay tuned. ----------------------------------------------------------------------------------------------------------------------------- ► Who is Darrin Carlson? Darrin Carlson has over ten years of experience in Quality and Regulatory in the medical device, pharmaceutical, and combination product fields. In addition to his current role as a Regulatory Affairs Specialist, he also helps small MedTech companies stay compliant with AI-powered, human-driven internal audits and publishes the QA/RA Playbook, a free weekly newsletter helping subscribers simplify compliance, empower innovation, and advance their careers. ----------------------------------------------------------------------------------------------------------------------------- ► Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. -------------------------------------------------------------------------------------------- ► Links from the Video ■ Darrin Carlson LinkedIn:    / darrinlcarlson   ■ Fix the Top 6 QMS Issues: https://qarasolutions.com/fixthetopsix ■ FDA page on Warning Letters: https://www.fda.gov/inspections-compl... ■ FDA page on 483 data: https://www.fda.gov/inspections-compl... ------------------------------------------------------------------------------------------- ► Social Media to follow ■ Monir El Azzouzi Linkedin:   / melazzouzi   ■ Twitter:   / elazzouzim   ■ Pinterest:   / easymedicaldevice   ■ Instagram:   / easymedicaldevice   ------------------------------------------------------------------------------------------ #easymedicaldevice #medicaldevice #regulatorycompliance