$50 per individual course. Once a course is purchased, you’ll be able to view the course one-time (within 48 hours from the time of purchase).
Call us about Annual Global License pricing: (415) 948-5220
Courses Currently Available
21 CFR 211: Pure, Safe, and Effective – This program reviews 21 CFR 211 with the reminder that all these rules help us produce a product that is pure, safe and effective. This program is a must for new employee orientation training at all levels of the organization.
Documentation Practices – This program provides a most interesting review of proper documentation practices for both paper-based and electronic record environments.
Equipment and CGMPs – This topic discusses the requirements of 21 CFR211 Subpart D – Equipment, specifically the design and construction requirements for equipment including lubrication and coolants. The class addresses cleaning and maintenance requirements including automatic and electronic equipment. The class also covers the requirements for equipment identification, and required documentation.
Courses Coming Soon
Buildings and Facilities
Surviving an FDA Inspection
Materials and CGMP
Organization and Personnel
Production and Process Control
Online FDA cGMP QSR GMP Training Courses – Give us a call: (415) 948-5220
“Despite the widespread adoption of technological advances, people still resist online learning. Although we may be quick to point the finger at older generations that did not grow up digitally, the resistance can come from any age group for any number of reasons.
Rather than discuss those reasons, I want to consider how we can overcome the resistance. Three ways I have found effective in practice are: highlighting the benefits, demonstrating the possibilities, and offering training.”
“However … Just like classroom training, online learning requires engagement at every level of the process. From upper management down to the learners themselves—there has to be some kind of engagement strategy in place. Without this high level of engagement, your training programme is doomed to failure. This means that your training’s return on investment is reliant on the amount of effort you put into effectively engaging your staff with their own self-development.”
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.
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.”