“The medical device industry hailed President Trump’s signing into law a bipartisan federal spending package that brings in an end to a tax the medical technology industry has been fighting against for the last decade.
The 2.3% tax on medical device sales that is part of the Affordable Care Act has already been on temporary hiatus since the beginning of 2016, but was scheduled to return at the end of this year if Congress didn’t eliminate the tax or put it on hiatus once again.”
“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.”
“The Site Selection Model (SSM), used by CDER staff to prioritize manufacturing sites for routine quality-related inspections, considers risk related to drug (drug substance and finished product) quality as may arise from violations of the CGMP requirements in the Food Drug & Cosmetic Act (FD&C Act).
The SSM will use risk factors consistent with section 510 of the FD&C Act, which identifies specific risk factors and allows FDA to determine additional ones, including: “a) The compliance history of the establishment. b) The record, history, and nature of recalls linked to the establishment. c) The inherent risk of the drug manufactured, prepared, propagated, compounded, or processed at the establishment.””
This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn what a class instructor thinks while delivering a training session to students, so you can repeat that training approach in your own organization.
This course is implemented in three phases: Awareness, Certification, and Master Trainer.
GMP Trainer Awareness – Students view presentations covering the course objectives below.
GMP Trainer Certification – Students view the “Awareness” presentations. Students then prepare elements of a training session demonstrating the application of the content taught in the awareness course, or in some cases, capture and submit video segments of an actual or practice training session. All information submitted will be reviewed and critiqued by a team of Master Trainers. This course is taken simultaneously with the Awareness course.
GMP Master Trainer – Learn GMP content to assure you know the basic GMP rules. This phase of the program is under development.
This is NOT a public seminar workshop. Our public seminar was so popular; we turned it into an online self-study course that fits into your busy schedule.
In this course, you will learn how to:
Apply a Participant Centered Approach to training
Write course objectives
Development a course assessment
Describe the difference between ice breakers and activities
Describe and develop ice breakers for a class
Describe and develop activities for a class
Explain the role of the instructor during activities
Develop an activity debriefing strategy
Describe various strategies for forming groups
Design a course presentation
Identify and demonstrate effective presentation skills
Develop stories for a class and how to deliver the story
Develop discussion questions
Develop and implement discussion follow-up strategies
Demonstrate the management of disruptive behavior
Identify the elements of a course assessment validation plan
Identify the elements of a course evaluation form
Develop a course evaluation form
Keywords: trainer certification, train the trainer, T4T, FDA, cGMP, QSR, GMP, 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 most popular class with Allan Dewes, “Root Cause Analysis and Investigation Report Writing” is now available as an online self-study course. In 3-1/2 hours you’ll learn about the tools used to conduct a thorough deviation investigation. You’ll also learn great tips and get clear guidance on how to write a deviation investigation report. This class is not just theory and offers clear examples. Private email-based coaching is also available.
Here’s what’s covered in the basic class:
Root Cause Analysis
GMP Compliance Requirements
Deviation Investigation Definitions
Deviation Investigation Teams
Interviewing and Path Forward
The Five Why’s Map
Understanding Human Errors
Previous Investigations (Look Back)
Follow-Up and Effectiveness Checks
Investigation Report Writing
Writing the Description of the Event
Event Classification Reporting
Writing Immediate Actions and Containment
Reporting on Previous Investigations
Sequence of Events (root cause discussion)
Root Cause Summary
Writing about Product Impact
Reporting on Corrections and CAPA
Reporting the Follow-Up and Effectiveness Checks
Background Information, Attachments and Referential Information
About the Coaching Option (an advanced option)
This optional purchase enables the student to practice each tool or report section. Each item is submitted to Allan for his review and evaluation. The student receives feedback. The purchase buys the student 4-hours of email-based coaching from Allan. Additional 4-hour blocks can be purchased if needed.
Basic Course access is $995 per student.
Advanced Coaching Option is $800 per student per 4-hour block of coaching time. Time is based on Allan’s actual document review time and preparing feedback. Additional review time segments can be purchased.