ia being presented by Alan Minsk, Partner, with Arnall Golden Gregory LLP and airs on Wednesday, December 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Supplier control has become a major focus area for FDA in recent years, and as such, an area which is seeing heightened enforcement efforts. This represents a significant challenge for medical device and pharmaceutical companies, who need to respond accordingly to ensure their supplier quality agreements will pass muster with FDA. The landscape is changing quickly, and those without the critical regulatory information will be ill-prepared for FDA scrutiny.
In this audio conference presentation, Alan G. Minsk, Partner and Chair of the Food and Drug Practice Team at Arnall Golden Gregory LLP, guides attendees through the critical points and the pitfalls to avoid when drafting quality agreements. The presentation addresses the vital legal and regulatory issues affecting pharmaceutical and medical device manufacturers, leaving attendees better prepared to meet customer and FDA expectations regarding supplier quality.
Showing posts with label supplier controls. Show all posts
Showing posts with label supplier controls. Show all posts
Thursday, December 1, 2011
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.
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.
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