Most GMP training that I encounter is not necessarily bad–just irrelevant. In fact the same could be said for the Training Department in general. They jealously guard their turf and deliver mediocre, perfunctory training. Names get checked off the list, and the Training Department goes about their business being irrelevant. (Ouch!)
There is nothing that could be more exciting and fulfilling than being part of a dynamic training group that equips its organization to be a finely tuned work force of scholars that embrace GMPs as a business enabler.
Unfortunately, rather than a graduate education in the pharmaceutics of regulations, our best and brightest are subjected to a mind-dulling deck of tired old PowerPoint slides.
Frankly, the problem is endemic and here’s why:
1. The concepts are not applied to the real world. We herd the mignons into the cafeteria and deliver the obligatory annual GMP training with total disrespect for what each employee does as part of his/her job everyday.
2. Training topics are not strategic. The lack of the broader view of the state of the industry and regulatory enforcement trends keeps GMP training from being proactive or responsive to the changing regulatory environment.
3. Training is not data-driven. The topics selected are often disconnected from the problems at the site as revealed at quality metric review forums such as Quality Management Review.
4. Training is the ubiquitous excuse (punishment) for corrective and preventive action. The easy out is to say that a failure can be addressed by training without truly determining the root cause.
5. The training method is not effective. When everything from a step change to a total system re-design is handled by “Read and Understand,” it is difficult to distinguish between minor and really significant training topics.
6. The trainers are dreadfully boring. It’s amazing how much we devalue the importance of training as evidenced by the little emphasis we place on the design and delivery skills we place on the people we put in those positions.
7. Lack of attendance is tolerated. When there is a conflict in one’s schedule, the training class is always the loser. Nothing ever happens if you don’t attend, because usually know one knows. No one really cares.
8. Leaders don’t go to training either. It’s comes down to not really expecting leadership to be trained, as though there is some special dispensation with the privileged class. They certainly aren’t examples to follow.
9. The priority of the production manager is getting product out the door, not the skills and capability of his/her workers. In fact, he/she may be totally unaware of whether the workforce is getting the right training, or current with meeting individual training requirements.
10. Measurable improvement in skills and knowledge is not rewarded. We reward what we value, and training isn’t it.
So, class, here’s your assignment:
Turn each of these negative statements into a positive one. Then perform a self assessment of your organization against these statements.
Don’t be defeated if the results are pathetic. You are in good company. It’s all about what you do with the information starting right now.
Turn these into vision statements. Discuss the practical, measurable steps you can take to improve the relevance of your GMP training.
Keep it going, and watch amazing things happen!
adapted and republished from the QA PharmSUBSCRIBE TO OUR MONTHLY NEWSLETTER>>