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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

Latest White Papers

An Engineer’s Guide to CAD and the Renaissance of Product Design

An Engineer’s Guide to CAD and the Renaissance of Product Design

Modern developers are either upgrading their technology or falling behind. Discover how new CAD technologies and other product design tools are altering the engineering space.What You Will Learn Discover how technologies like Creo and Creo+ from PTC are helping...

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An Engineer’s Guide to CAD and the Renaissance of Product Design

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Modern developers are either upgrading their technology or falling behind. Discover how new CAD technologies and other product design tools are altering the engineering space.What You Will Learn Discover how technologies like Creo and Creo+ from PTC are helping...

Optimizing Design with PTC Creo and Windchill Integration

Optimizing Design with PTC Creo and Windchill Integration

Meeting the highest levels of product quality requires leading engineering and manufacturing teams to utilize integrated solutions. Bringing together advanced CAD and Product Lifecycle Management (PLM) capabilities can lead to lower costs and increased innovation....