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CAPA: A Review of 21 C.F.R. §820.100 and FDA Warning Letter Trends

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.

Learn more about IT FDA requirements and compliance training best practices to help your business gain the competitive market advantage

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A Checklist for Reducing Time to Market in Engineering

Product teams all have the same goal: produce high-quality products and reduce time to market. Achieving these goals simultaneously can be difficult, but your team doesn’t have to sacrifice one for the other. Learn how in this eBook.What You Will Learn In this eBook,...

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