“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).
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.
“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.”
Expertise – We’ve been delighting clients for more than 20 years. Allan Dewes, President & master trainer, combines his regulatory knowledge and operations experience to meet your needs. He’s personable, an active listener, and a trusted partner to 100s of satisfied domestic & international clients. He helps clients succeed.
Live GMP Training – Leadership and course participants rave about our onsite courses. These popular courses are considered interactive, engaging, relevant, and sometimes fun! Students want to be in our classes, instead of trying to find ways to avoid going to class.
SkillsPlus Intl Inc. can be your one-stop shop that: meets your needs, wows students, and makes your training delivery easier!