PhM: You’ve had an increased focus on training within your company, and we’re seeing it within FDA and the industry in general. What explains it?
Ciambrone: We have always focused a lot on training. And that has to do with the industry we’re in. In the biotech sector especially, you’re talking about fairly complex processes. In order to keep your costs where you want them to be, you certainly can’t hire PhD scientists to execute manufacturing all the time.
And as much as you try to make the processes either automated or fairly foolproof, the fact is that some of them require a really well-trained workforce. So for sound business reasons, we’ve always focused on the training of our employees.
What you say about focus from the Agency is true as well. They recognize that there are so many deviations that are related to training. I would venture to say that in many instances, manufacturing failure is oftentimes due to a failure to properly train personnel. It’s one thing that comes up when we look at deviations and investigations—have our people been appropriately trained so they can perform their functions adequately?
PhM: Is it your sense that the deeper that FDA digs into this, the more they’ll find that manufacturers are not training their staffs comprehensively?
Ciambrone: My guess would be that they have already seen a lot of these things. They will find, perhaps, that there are a lot of ways to skin a cat. There are different ways of training. So they’ll probably focus on what the fundamental goals in training programs are.
My sense is that most pharmaceutical companies have what they consider a well-documented training program. The problem is not can you properly document what people are trained on, but do you have a way of assuring that what they’re trained on is what they need to know? They need to develop a curriculum of baseline things workers need to know, and develop training that is programmatic.
And most importantly, how do you verify that training is effective? This is what companies really struggle with. It’s so hard to demonstrate.
PhM: How do you measure that your training is effective, and how has that changed over the years?
Ciambrone: We’ve taken the approach where the simple documentation of training to an SOP is really only the first step. We’ve follow that with a proficiency assessment that includes having a supervisor verify or validate the practical training. So that in order to perform an operation, it’s certainly not just familiarity with the SOP that’s required of you, but actually practical training on the floor, witnessed by supervisors and signed off on by the appropriate level of management, so that there’s accountability that the person is trained.
Training is really the responsibility of the management, but the employee as well. It’s important to have that dual responsibility, a system of checks and balances.
I don’t know that we or anyone else has the back end of that worked out completely yet. Now that a person’s qualified and someone has signed off on that, how do you follow up on the effectiveness? Are you monitoring that performance over time, employee by employee? That’s the next generation for most companies.
PhM: That is a challenge, monitoring and maintaining over time. How are you coming to grips with that?
Ciambrone: All manufacturers should be monitoring the success of their operation and looking at their batch and process success over time. Typically, most companies look at those things when they need to, in terms of something going awry and tracking back to the root cause. They triangulate on, “we’ve had these three or four events and the same group of people involved in each one—we might have to retrain them.”
It’s very much retrospective or reactive. People probably do a good job of that responsive aspect of training or retraining. What I don’t think is common is that as part of normal batch review and process monitoring, are we tying those things back to appropriate training?
What we’re doing is trying to figure out a good, robust approach to the training curriculum. We make sure that all the required training is actually put in prior to the beginning of the GMP operations. And then we need to make sure that we are keeping people’s training current. That means that as SOPs are revised and batch records or processes have changed, then we go back and review our training to make sure it is complete.
PhM: How are you doing that? Is it automated?
Ciambrone: Yes, we have a pretty robust training database which has, position by position, the requirements for individuals. So when an SOP or process is revised, we go back and make sure they have the training they need. It would be hard to do without automation.
PhM: Is that database something that you customized in house or bought off the shelf?
Ciambrone: It’s a customized off-the-shelf system. And we have a Quality Management Software system that links into it. Many people have a quality management software module that they can use—they just need to apply it. We are also increasingly using Electronic Learning Management systems or ELMS. This provides targeted training with very consistent content and the ability for defined proficiency assessments or tests to verify the effectiveness of the training. It’s not just reading SOPs anymore.
PhM: A lot of companies say training is a necessary evil. How do you get a culture in which good training is really something that everybody wants and demands?
Ciambrone: To be honest, I would be afraid of a company that took the attitude you talked about. Good training is a literal cornerstone of good GMP. Not just because it’s required by the regs, but because we are relying upon the employees to execute a function. In our case, our product is extraordinarily expensive, and we spend a lot of money on equipment and facilities.