“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.
“The rise of Millennials in the workplace has led to endless articles about the challenges of “adulting”. It turns out many adults don’t feel grown-up. So, what defines adult learners and how do they differ from younger audiences?”
“On October 31st, FDA made its long anticipated announcement recognizing the first European drug regulatory authorities capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight countries that were announced are: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom.”
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.
“Fast-paced organizations need just-in-time (JIT) learning. Nano or micro-learning gives learning managers a quick and simple way to adapt to the fast-changing needs of their learners. In this article, I’ll show you how to create nano-learning in under 15 minutes.”