Monday, June 21, 2010

The FDA’s New Emphasis on Supplier Controls – What Device Manufacturers Need to Know

is being presented by Vinny Sastri, President, of Winovia LLC and airs on Thursday, July 29th, 2010. For more details or to register, please visit our site at www.fxconferences.com

The FDA will be putting a lot more emphasis on purchasing controls and supplier selection and audit requirements for medical device manufacturers. In December of 2008 the Global Harmonization Task Force issued a guidance document on “the Controls of Products and Services Obtained from Suppliers” detailing the requirements and expectations manufacturers must meet to exert more control over their suppliers.

This audio conference presentation reviews those expectations and the details of the new guidance document, and also discusses how these new requirements affect medical device manufacturers. Our speaker also looks at how design and development, risk management and process controls are intricately linked to purchasing controls.