Outsourcing and Offshoring in a New Era of FDA Enforcement

Jack Garvey |

On Thursday, March 11, 2010, Jack Garvey, Principal, Compliance Architects LLC, will be presenting an audio conference in conjunction with FXTranslations  and FXConferences entitled “Outsourcing and Offshoring in a New Era of FDA Enforcement.”    This audio conference will be of great help to companies that use contract product or service providers, either within the US or outsideof the US.    From the conference registration page:

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.

This audio conference covers:

  • How to select a contractor
  • Managing contract relationships
  • Elements of the quality system interface
  • Current FDA requirements & expectations
  • How the FDA might change its approach
  • What your company should be doing over the next 18 months

To register for this important event, please visit the FXConferences registration page.

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