“In this article, we will discuss the basic differences between eLearning and classroom learning based on 4 important factors, such as time, freedom to study a course of one’s own choice, degree of understanding, and cost-effectiveness.”
New employee GMP training awareness that is quick and easy?
Annual refresher training that is on a flexible schedule for team members?
Training solutions that are responsive to a demanding production environment?
Our LMS GMP training solution is the answer to your needs!
A current list of topics is available
An ever growing list of topics is planned
Our pricing is structured for today’s tight budgets
Private classrooms allow your company trainer to share notes to all your employees.
Trainers can be identified as classroom monitors to tracking student grades and completion.
Courses Currently Available
21 CFR 211: Pure, Safe and Effective – An overview of the Current Good Manufacturing Practice Regulation.
Proper Documentation Practices – An explanation of the GDPs for paper and electronic records.
Equipment – A review of equipment related GMPs.
Root Cause Analysis – An in-depth examination of the most effective tools for investigation deviations. Individual deviation specific feedback and coaching is available.
Investigation Report Writing – This course offers an in-depth examination of the FDA and QA expectations for writing a comprehensive investigation report. Individual report specific feedback and coaching is available.
“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.”
“This New Inspection Protocol Project (NIPP) uses standardized electronic inspection protocols to collect data in a structured manner for more consistent oversight of facilities and faster and more efficient analysis of our findings. The protocols also include additional questions related to quality culture observed in facilities. The new tool is being applied to our inspectional work related to sterile injectable drugs, which have been the subject of sterility problems and shortages in the past. The primary focus of this new tool is to ensure a more streamlined and consistent coverage and reporting of our inspectional activities.”
“These aseptic processing drug inspection protocols for sterile drugs are the first of what we plan to be a series of valuable new inspection protocols covering all dosage forms. As we integrate learnings from these pilots in our field activities, our goal is to have them ready for full implementation within the next two years. These modern tools are a key part of our efforts to protect the health and safety of U.S. patients.”