Monday, May 30, 2011

FDA Wants Resource Planning In Corrective Action Plans

According to the The QA Pharm blog,
"The most successful corrective action plans have been those where the direct responsible individuals are named and appear in detailed project plans. There is a clear picture of what success looks like and how to get there. But most of all, the resources are identified to execute the work."
Apparently in an FDA Warning Letter to Teva early this year,  the FDA is telegraphing their desire to see these kinds of elements in a response:
  • a plan
  • what kind of data will be collected to measure the effectiveness of the plan
  • a timeline for the plan
  • the identification of resources allocated to address the issue
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