The Impact of Supplier Quality on Your Bottom Line and Your Company's Risk

• University City Science Center

Medical device manufacturers are becoming increasingly dependent on suppliers of raw materials, parts, and even components or entire medical devices. These suppliers may be situated locally, across the country or in a developing country halfway around the world. Regardless of where the supplier is located, it is essential that the manufacturer establish efficient and rigorous supplier control programs to assure the quality of the materials and products used in finished medical devices. Supplier quality problems have been at the center of issues regarding recalls, adverse event reports, and good manufacturing practices noted recently in warning letters. The impact of supplier quality on your bottom line, reputation, and risk cannot be underestimated.

Panel Speakers:
Steven Niedelman, Crowell & Morning
Dan Miller, Inteprod, LLC
Jason Clevenger Exponent, Inc.

Highlights that will be discussed by this panel include:

* What issues have appeared in recent warning letters leading to recalls regarding supplier quality?
* Qualifying a supplier—what should their quality and risk management systems be like?
* How should you audit a supplier?
* How much of the increased regulatory burden should suppliers share?
* The importance of considering second tier supplier issues
* What if you need to change a supplier?
* What are the risks of depending on single source and sole suppliers?
* How should you optimize cost and quality in your selection of a supplier?
* Where are most of the supplier quality problems taking place geographically?
* How do you handle communications between a supplier and FDA?

Please join us for this panel presentation. A continental breakfast will be served at 7:30am.