SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends. One of the problem areas most often cited in company audits continue to be the CAPA system/program. This month we will take a look at some of the latest FDA Warning Letter data, review some of the essentials of a well-designed CAPA system, and list some of the tools available on the market to help your organization establish a solid CAPA program.
We invite you to download our paper on this topic.
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