On June 6th, 2013, in a conference room in Bethesda, MD, two former high-ranking FDA veterans, Martin Browning and Janis Olson led a one-of-a-kind strategy session on how to create a bulletproof medical device supplier quality system.
For the attendees in the room, getting first-hand insight from their 44 years of experience was a goldmine. Now you can have that goldmine too.
Here are a few of the questions attendees asked…and got answered.
· Is a company that only distributes a product without placing its name on the product responsible in the eyes of the FDA for problems with the product?
· What do you do if a supplier refuses to share information about its sub-suppliers?
· Do FDA inspectors expect documents from foreign suppliers to be translated into English?
· Will the FDA inspect raw materials and components suppliers without cause?
· How do you determine whether a product is a component or finished device?
· In what cases might a supplier deny manufacturers access to its CAPA system?
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