spk-logo-tm-2023
0%
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

A Guide to Ensuring CAD Success in Virtual Environments

A Guide to Ensuring CAD Success in Virtual Environments

As the shift to cloud-based CAD increases, businesses are searching for the perfect virtual CAD tool. Discover all about SPK vCAD as well as other virtual CAD options for collaborative design on this eBook.What You Will Learn In this eBook, you will discover: Future...

Related Resources

A Guide to Ensuring CAD Success in Virtual Environments

A Guide to Ensuring CAD Success in Virtual Environments

As the shift to cloud-based CAD increases, businesses are searching for the perfect virtual CAD tool. Discover all about SPK vCAD as well as other virtual CAD options for collaborative design on this eBook.What You Will Learn In this eBook, you will discover: Future...

Speed, Scale, or Security? What gets prioritized first?

Speed, Scale, or Security? What gets prioritized first?

In this episode of All About Accelerating Products, we chat with Vish Reddy, co-founder of Revyz, a secure backup and data audit solution built for Atlassian cloud products. Vish walks us through the moment that sparked it all and how that frustrating experience led...