Cathy Burgess presented, "Supplier Control Study:Maintaining Quality and Reducing Risk," during this conference sponsored by FDA News
. Medical device manufacturers are becoming increasingly dependent on third-party suppliers of raw materials, parts, subassemblies and even suppliers of original equipment. 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 devices.
There have been a number of recent high profile press reports of recalls, deaths and injuries associated with FDA-regulated products. All of these have been the result of supplier quality problems. These reports have refocused the FDA’s attention on the importance of ensuring that appropriate purchasing controls are in place to assure quality. The following topics were covered during this presentation.
Assist in developing a risk-based supplier quality program based on the case study
Determine different ways to assess suppliers based upon risk
Learn the importance of developing solid contractual agreements and change control procedures
Understand the importance of supplier quality and its relevance to FDA’s quality system requirements
June 3-5, 2009
Royal Sonesta Hotel Boston / Cambridge, MA