Month: August 2023

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:

  1. Awareness: Participant says, “I’ve heard that!”
  2. Understanding: Participant recognizes the subject matter and then explains it.
  3. Practice: Participant actually uses the learning on the job.
  4. 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.