How to Prepare for Your Next FDA Inspection
Medical Device Academy
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How to Prepare for Your Next FDA Inspection
7 330 просмотров · 8 лет назад
Medical Device Academy
10,6 тыс. подписчиков
7 330 просмотров · 8 лет назад
This free one-hour webinar provides a basic overview of how to prepare for an FDA medical device inspection. Please note the first 5 minutes of the video is audio only.
FDA Inspection Webinar Topics include:
-FDA’s approach to conducting inspections
-How FDA prioritizes their inspections
-QSIT approach-7 major and minor sub systems
-Types of FDA inspections
-Management review, internal audits, supplier audits – Which -documents FDA may request
-“Back room” preparations for organizing the inspection
-FDA 483s – Wording, Most common 483s in 2013
For more information or for help preparing for an FDA Inspection or scheduling an Audit please visit our website at-
http://medicaldeviceacademy.com/