In my first FDA inspection, the guy showed up in dungarees and all the trappings of law enforcement. He showed up unannounced, spoke with the head of test and reliability for a bit, then got a time to come back, to give us time to get ready. It was a bit of a fire drill to get ready. Even then, we still got 483d over risk file deficiencies. Not as traumatic as yours, but the aftermath was not handled well.
Thank you for sharing your experience with an FDA inspection. What inspectors wear varies a lot now, and for inspections in the USA they will normally call ahead (by a day or two). However, in some cases the inspector is in the neighborhood and they may just drop by. If you want to learn more about how to prepare for an FDA inspection, try purchasing our work instruction: medicaldeviceacademy.com/fda-inspection-webinar/ For after the inspection, you will need to use your CAPA process: medicaldeviceacademy.com/capa-procedure/
@@MedicalDeviceAcademy yep. The CAPA gave me the opening to write and implement my first quarterly risk review cycle using FMEA to keep the risk file current. Also included complaint and investigation summaries, etc. This was in addition to any updates required on a change to the product, labeling, etc.
Great suggestion. I have not put a lot of video content out about validation, but that is a big part of my background. Validation can include design validation, process validation, software validation, and validation of automation. Did you have a specific are you wanted me to cover? Feel fee to email me directly - rob@13485cert.com
In my first FDA inspection, the guy showed up in dungarees and all the trappings of law enforcement. He showed up unannounced, spoke with the head of test and reliability for a bit, then got a time to come back, to give us time to get ready. It was a bit of a fire drill to get ready. Even then, we still got 483d over risk file deficiencies. Not as traumatic as yours, but the aftermath was not handled well.
Thank you for sharing your experience with an FDA inspection. What inspectors wear varies a lot now, and for inspections in the USA they will normally call ahead (by a day or two). However, in some cases the inspector is in the neighborhood and they may just drop by. If you want to learn more about how to prepare for an FDA inspection, try purchasing our work instruction: medicaldeviceacademy.com/fda-inspection-webinar/
For after the inspection, you will need to use your CAPA process: medicaldeviceacademy.com/capa-procedure/
@@MedicalDeviceAcademy yep. The CAPA gave me the opening to write and implement my first quarterly risk review cycle using FMEA to keep the risk file current. Also included complaint and investigation summaries, etc. This was in addition to any updates required on a change to the product, labeling, etc.
Hey Rob, love your channel. Would you be able to post some Validation related content? I'm a new CSV and I'm learning a ton from you
Great suggestion. I have not put a lot of video content out about validation, but that is a big part of my background. Validation can include design validation, process validation, software validation, and validation of automation. Did you have a specific are you wanted me to cover?
Feel fee to email me directly - rob@13485cert.com