1-888-310-4540 (main) / 1-888-707-6150 (support) info@spkaa.com
Select Page

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

The Next Chapter of Jira Service Management

The Next Chapter of Jira Service Management

The service industry is only becoming more competitive as the years pass, making efficient delivery vital to success. Development and Operations teams need to work together to deliver aid and Jira Service Management can help achieve this. [et_bloom_inline...

Related Resources

Exploring Modern Software Deployment Strategies

Exploring Modern Software Deployment Strategies

Deploying software can feel like a gamble due to all the strategies and solutions on the market, but it doesn’t have to be. Discovering which software deployment strategy works best for your organization is a great place to start. This strategy, combined with a modern...

Automatically Visualizing Dependencies in Codebeamer

Automatically Visualizing Dependencies in Codebeamer

If you work in the software and systems engineering space, you likely understand that managing dependencies across multiple components and requirements is critical for project success. Unfortunately, specifications can be difficult to track, and dependencies hard to...