Valuable CAPA System Information and Help

This site is devoted exclusively to the CAPA world (Corrective Action - Preventive Action). Here you can find information, counseling, training and almost everything related to root cause, investigations and the CAPA world. Our focus are the life-sciences regulated industries (a.k.a FDA regulated firms) and we can help your company wherever your are located (literally) and whoever regulated you.

Best seller book"CAPA FOR THE FDA-RELATED INDUSTRY" published October 15th 2010 by ASQ Quality Press.
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Medical devices, biopharmaceutical, and traditional drug manufacturing companies devote an important part of their resources to dealing with incidents, investigations, and corrective and preventive actions. The corrective and preventive action system is known as the CAPA system. It is second to none in terms of frequency and criticality of its deviations, and most of the regulatory actions taken by the FDA and foreign regulators are linked to inadequate CAPA systems. This guidance book provides useful and up-to-date information about this critical topic to thousands of engineers, scientists, and manufacturing and quality personnel across the life sciences industries.-

Understanding and improving the CAPA system as a whole is the focal point of this book, the first of its kind dealing exclusively with this critical system within this highly regulated industry. By helping those in this industry improve their CAPA systems, it will be a crucial aid in their mission of producing safe and effective products.

Investigation and CAPA system Helper

Need some help with your CAPA System?. Ineffective CAPA, past-due investigations, no root cause found?, a lot of human error and re-training? Sound familiar?. Things can become even worst: audit and inspection observation, warning letters, etc... We can provide very cost-effective help to improve your CAPA system. You will get a more robust CAPA system. Easy as can be! MORE >>

Coaching and Consulting

Improve your root cause analysis and CAPA procedures and instructions
Stop the abuse of the human error (or procedure not follow) "root causes". They are consequences not root causes. Learn how to perform effective investigations on these situations.
Most firms are just trying to prepare their CAPA system for inspections. Our approach is different: we can help you to create a robust, state-of-the-art and inspection proof CAPA System. MORE >>

Training and Development

CAPA Expert certification. Learn more>
Technical and Compliance Writing
Human Errors and Human Factors in the FDA regulated environment
Process monitoring and trending
for more Quality training visit www.calidadpr.com
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Audit of the CAPA system

We are specialist in the CAPA system and we are very good! Your firm will benefits from an external assessment of the CAPA system that can be extended to all management control activities (management controls, training, internal audits). MORE >>

CAPA Q&A

Looking for some CAPA answers? Read a few dozens of interesting questions and some clarifying answers, organized by topics. If your question is not part of the selected topics, do not hesitate to contact us and we will do our best trying to helping you. MORE >>

Download

Here are pdf copies of presentation and regulations more often requested by our clients. Also, a few of our good templates (investigation report, corrective action, preventive action) are available for free downloading. MORE >>