Insiders Guide To Supplier Quality Success

DVD – multi-user single site: The Insider's Guide to Supplier Quality Success

August 2014
Also Available:

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?