{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F7dc4f6df-1310-4123-a2b1-ac902d1de750","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Tips to Help You Prepare for an FDA Inspection","description":"On today\u2019s episode, we\u2019re introducing the newest addition to the greenlight.guru team, Jessica Lyons.\n\nJessica is a 2007 graduate of Rose-Hulman Institute of Technology and has worked in the medical device product development for nearly 10 years.\n\nShe worked in custom integration at Beckman Coulter, then worked on getting medical devices transferred to manufacturing at CRI, a medical device contract manufacture.\n\nJon and Jessica are discussing FDA inspections.\n\n\u201cIt doesn\u2019t matter your size, shape or how long you\u2019ve been around. You\u2019ll go through an FDA inspection.\u201d \u2013 Jon Speer\n\nNo one looks forward to having the FDA come to inspect their facility, but you always need to be ready for it, as you might be subject to an inspection as frequently as every two years.\n\nWe want to put your mind at ease by giving you information on how to best prepare for FDA inspections, which can take a minimum of five to seven days.\n\n\u201cThe FDA seems to find the one piece of information you wish they wouldn\u2019t.\u201d \u2013 Jessica Lyons\n\nSome of the topics you\u2019ll hear about it in today\u2019s podcast include:\n\nJessica talks about her role at greenlight.guru, which is making sure the customers are successful, in whatever form that takes.\n\n- Why FDA inspections are high-stress.\n- How to prepare for an FDA inspection.\n- What to expect during your inspection?\n- Why the FDA nearly always finds potentially questionable items.\n- How to react if you receive a 483 warning letter.\n- What to do in order to resolve issues found during your inspection.\n- What FDA data is available to the public.\n\nNow if you liked today\u2019s episode, then I know you\u2019re going to find the free webinar we have coming up valuable. It\u2019s titled, \u201cHow to Avoid and Respond to FDA 483\u2019s and Warning Letters.\u201d\n\nYou can register for the webinar here: http://www.greenlight.guru/webinar/fda-483-warning-letter-response","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/460fbc8b-b13b-44b1-8079-d66a669f201a/0ae1b4c1-be27-41fa-bb21-ffe697efa066.jpg"}