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.
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).
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.
” . . . it comes as no surprise that the use of video in E-Learning is on the rise. Accompanied with an influx in the use of digital storytelling as an educational tool, videos are a fun approach to creating bite-sized and engaging E-Learning modules.”
. . . In addition to images, you may want to consider using a wide range of multimedia elements to increase immersion and appeal to all senses. For instance, you can integrate video and audio components that create a more interactive and engaging eLearning environment.”
“If you already implement online training, then you’ll want to assess how you can improve your online training courses/modules/events to get the most out of your training efforts. Are there modules that may need to be shortened or lived up by adding graphics and/or videos? Are you updating your online training courses regularly so that employees can find out about the latest products or services your company is offering?”
“6. Include audio or video to create a more immersive experience. Audio or video integration is ideal, especially if you are trying to make your eLearning presentation more dynamic and interactive. Narration, background music, and video explanations are all examples of multimedia tools that you can and should use.”
Help your learners by breaking down your course material into easily digestible “chunks” of course content.
Chunking GMP content helps learners process and understand information better.
The chunking technique applies to teaching and training GMPs too. For that reason, we’ve launched a new product line, The cGMP Mini-Series. The mini-series is designed as brief 6-10 minute long video clips that you can insert into your Powerpoint slides, or LMS (learning management system) courses.