Train-the-Trainer

A firm requirement throughout the GxP regulations and the various ISO standards is that individuals are appropriately trained and qualified to do their work.

Inevitably, that appropriately trained and qualified comes down to the trainer who is conducting the training. How do we train our trainers to ensure that individuals are learning and acquiring all of the skills, knowledge, and insight they need to perform their roles well.

Inadequate training is a consistent finding across the GxPs, so you have to ask are we training our trainers to an appropriate level to make the training effective? Equally important you are spending a lot of time and money training people so you want it to be effective and worth the resources spent.

There are really two options for trainers: 1. Trainers who become qualified to teach a course and 2. SMEs who are qualified to be trainers. In either case, you need that qualification mechanism to ensure your trainers can train. I’ll be honest for technical material I prefer SMEs being trained to be trainers as the experience is usually a whole lot better for the trainee.

This training focuses on being able to deliver informal and formal learning solutions in a manner that is both engaging and effective. Be able to:

Manage the learning environment.
Prepare for training delivery.
Convey objectives.
Align learning solutions with course objectives and learner needs.
Establish credibility as an instructor.
Create a positive learning climate.
Deliver various learning methodologies.
Facilitate learning.
Encourage participation and build learner motivation.
Deliver constructive feedback.
Ensure learning outcomes.
Evaluate solutions.

This qualification path will prove itself valuable.Through this we can ensure that our trainings meet their four objectives and that participants can demonstrate:

Awareness: Participant says, “I’ve heard that!”
Understanding: Participant recognizes the subject matter and then explains it.
Practice: Participant actually uses the learning on the job.
Mastery: Participant can use the acquired knowledge to teach others.

Being a trainer is critical for true subject matter expertise and process ownership.

And as an aside, notice I didn’t include instructional design, this is where your training team can really add value!

Timeliness in Deviations is Important

Looked one way, the recent Intas Warning Letter is another example of a foreign company that should not be in the business of manufacturing pharmaceuticals. And that is probably true.

However, even the most egregious document can have some nuggets of wisdom for more mature quality organizations. Take this observation:

An analyst destroyed CGMP records by pouring acetic acid in a trash bin containing analytical balance slips for testing the standardization of (b)(4). A QC employee stated he observed the same analyst destroy KF titration curves and balance printouts. The employee reported the incident to QC laboratory management on November 22, 2022. An investigation into the destruction of the torn CGMP documents and the impact to your drug product quality was not initiated until November 28, 2022.

I sincerely hope you don’t have anyone pouring acid in a trashbin, or putting original data in a trashbin, or pouring acid on original data in the waste bin. But often we focus on the huge issues, shrug and say “That doesn’t happen here.” And hopefully you are right.

It is the last sentence that actually drew my attention. Because this gets to a problem we see in many organizations, some of them rather mature – timely creation and investigation of an event.

Managing Events Systematically

Also it is a telling example of poor inspection conduct. Don’t drag your heels with the inspector is clearly right. Act and act fast.

A task is a task is a task

It never ceases to amaze me how many ways an eQMS can subdivide a task. CAPA actions, change actions, meeting actions, supplier actions, etc, etc, etc. It is dizzying.

Tasks are all the same. They comprise of an objective, which is they why. A task (the who, when, what) and a deliverable (proof it is done)

I can count some off the shelf eQMS platforms that have 6+ workflows for this. Absolutely no need. It just makes the end user confused.

Just a little rant brought to by my favorite activity, implementing and improving eQMS functionality.

Designing Level 2 Training Effectiveness Assessments

In the Kilpatrick model, a level 2 assessment measures how much individuals learned. It is asking did the learners actually learn what we wanted them to learn? Did we actually advance knowledge?

For many of us, the old go-to is the multiple-choice quiz.

Measuring Training Effectiveness for Organizational Performance

If we actually want to assess a learner’s ability to do something or think critically about a topic, a multiple-choice quiz isn’t going to work. This isn’t to say that a multiple-choice quiz can’t be challenging, but the focus of a multiple-choice quiz is on the learner’s understanding of the content, not on the learner’s knowledge of how to apply the content to a variety of different contexts.

Say we are designing a root cause analysis course. By the end of the course, your learners should be able to understand some core principles of root cause analysis so that they can perform better investigations, find root causes and determine appropriate CAPAs. While there may be some inherently wrong approaches to root cause analysis that could be assessed in a multiple-choice quiz, a skilled investigator will likely not be dealing with obvious “right” and “wrong” ways to identify causes. Most investigations require complex interactions with people. As such, there may be multiple decisions an investigator needs to make and, within the scope of a course, it could be really hard to identify what skills a budding investigator needs to develop through multiple-choice quizzes alone.

So, what kinds of assessments could you use beyond multiple-choice quizzes and when should you use them? There’s a lot of complexity to these choices which ultimately need to align what
you want people in the course to learn with how you think they can best demonstrate evidence of that learning.

Assessment Instrument	When to use it	Example
Multiple-Choice Quiz or Exam	To assess a learner’s understanding of a concept, definition, or specific process. Could also be used to assess responses or reactions to a scenario-based question if there are clear “right” or “wrong” responses.	Understanding of core concepts of root cause analysis. Simple branching choices, for example what tool to use when.
Open-Ended Questions	To assess a learner’s ability to interpret and apply a new idea. Could also be used to assess a learner’s ability to describe an approach to a process or problem.	Demonstrate knowledge of root cause analysis techniques through various practice exercises.
Long-Form Written Assignment	To assess a learner’s ability to make an argument, analyze a text or current event, or use outside evidence to inform a particular claim. Could also be used to assess a learner’s understanding of how to produce a piece of writing specific to a particular field or discipline (for example, a lab report in a lab sciences context or a policy memo in a public policy context).	Write an analysis and investigation report up from a example.
Project	To assess a learner’s ability to make a new product and apply skills learned to build an independent work. Could also be used to assess a learner’s understanding of how to create a field-specific artifact.	Conduct a root cause analysis from an exercise. On the job training.
Portfolio	To assess a learner’s ability to grow, revise, and create a body of work over a particular period of time.	Review of investigations on periodic basis

Assessment Types

A lot of learning experiences will implement a combination of these types of assessments in a course, and it’s likely that at different phases of your course and for different purposes, you
will need to select more than one assessment or evaluation method.

Remember that an assessment serves two additional purposes: It helps the learners recognize where they are in the course so that they have an understanding of the progress, and it helps you, as the facilitator, see what challenges and triumphs the learners are experiencing all the way throughout the course.

FDA Revised MAPP Impact to Foreign Inspections

The FDA has updated its MAPP for staff, revising the “Understanding CDER’s Risk-Based Site Selection Model” (5014.1 Rev. 1). The update details how the FDA will prioritize inspections under the SSM and adds a risk factor for establishments in countries with a history of violations. This is a new risk factor for a region or entire country, whereas previously, mainly individual criteria such as site quality history, site type, and time since last inspection were used.

This is a fascinating addition, and I’d love to see the actual data on this risk factor. Anyone know if this can be FOIA’d? It would be interesting to see the difference between India and Mexico or even if they’ve subdivided the US.