“On October 31st, FDA made its long anticipated announcement recognizing the first European drug regulatory authorities capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight countries that were announced are: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom.”
The FDA says, “Human error is not a root cause.” If your first reflex is blaming human error, it’s time to re-think the situation in order to identify the real root cause of the human error.
There are several categories of human errors: slips, lapses, and induced errors. These can account for a large percentage of errors. In order to understand these human errors in more detail, they can be investigated through the use of investigative tools such as a Walk Through Analysis or Control Barrier Analysis.
Once the underlying contributing factors and real root cause(s) are understood, then they can be controlled (in many cases).
Advanced cGMP Training – Root Cause Analysis & Deviation Investigation Report Writing
Pinpointing the wrong root cause can result in ineffective immediate, corrective, and preventive actions. Throwing fixes at the wrong things might not fix the problem. Blaming and overusing human error as the root cause can result in incomplete and ineffective root cause analysis. By taking our advanced courses, you’ll more confidently identify the real root causes, and craft clearer and more concise investigation reports.
These highly popular advanced cGMP training classes are taught at the location of your choice. You might be interested in two of our highly popular and inter-related courses.
“Fast-paced organizations need just-in-time (JIT) learning. Nano or micro-learning gives learning managers a quick and simple way to adapt to the fast-changing needs of their learners. In this article, I’ll show you how to create nano-learning in under 15 minutes.”
One of the top reasons for a company to receive a 483 is a deficiency in the deviation investigation process. In this onsite hands-on workshop, employees learn the most effective tools to determine the real root cause of the problem. Attendees use actual plant deviations to practice the use of the tools. Allan Dewes (SkillsPlus International Inc.) has taught this course all over the world with exceptional results.
” . . . figuring out how to integrate learning technology tools most effectively can be tricky and time consuming. There are, however, some blended learning best practices you can follow to implement a blended learning program that boosts employees’ performance and gets them excited about using learning technology to their advantage.”
“Learning facts is difficult, but assimilating a story is something that comes naturally to most of us. Read how using storytelling for compliance training helps compliance learners not only absorb information, but also change their behaviors.”
“It can be overwhelming to think about restructuring a program, but you can start small. Assess which parts of your curriculum are best suited to becoming bite sized. Rebuild just a portion, changing a few courses in your overall training solution. Or begin building new programs with micro elements.”