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The QA Pharm

Quality Insider

Top 10 Ways to Make GMP Training Relevant

Turn these negatives into positives and watch amazing things happen

Published: Friday, October 21, 2011 - 15:09

Most good manufacturing practices (GMP) training that I encounter is not necessarily bad, just irrelevant. In fact, the same could be said for most training departments. They jealously guard their turf and deliver mediocre, perfunctory training. Names get checked off the list, and the training department goes about its business of 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 workforce of scholars that embraces GMP 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 are the top 10 reasons why:

1. The concepts are not applied to the real world. We herd the minions into the cafeteria and deliver the obligatory annual GMP training with total disrespect for what each employee does as part of her job every day.

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.

4. Training is the ubiquitous excuse (read: 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 redesign 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 how little emphasis we place on the design and delivery skills of 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 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 setting examples to follow.

9. The production manager’s priority is getting product out the door, not the skills and capability of his workers. In fact, he may be totally unaware of whether the workforce is getting the right training, or is even 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.


About The Author

The QA Pharm’s picture

The QA Pharm

The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).


Re: Strategic GMP Training Course

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