The increasing use of outsourcing and offshoring by FDA-regulated companies for strategic and cost purposes has greatly improved business outcomes and efficiencies. Unfortunately, despite the clear benefits, there are many significant challenges to structuring and managing these relationships to minimize the risk of FDA enforcement, particularly in the new, more aggressive FDA enforcement climate.
In this audio conference, our speaker provides some business context regarding the use of offshoring and outsourcing, and discusses issues and considerations in structuring relationships, as well as considerations in planning for FDA review and inspection of oversight programs.
Outsourcing and Offshoring in a New Era of FDA Enforcement is being presented by John Garvey, Principal, with Compliance Architects, LLC and airs on Thursday, March 11, 2010. For more details or to register, please visit our site at www.fxconferences.com
