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.
Most companies spend an awful lot of money on plant and facilities. I find it bizarre to not also invest in training, as if somehow you’re naturally going to get qualified employees off the street. You can’t rely on the old, “follow me around for a couple days and we’ll do on-the-job training.” That’s what you would see in factories 20 years ago. These products are highly complex, the processes highly automated, there’s lots of computer interface. People are a key resource that we invest in, and it’s only good business to make sure that they’re adequately trained.
PhM: Is it also a competitive advantage when you’re trying to lure top people to your company?
Ciambrone: We think so. People want to be successful when they join a company. Giving them good training and all the tools they need, you can attract better employees and keep them more motivated because you’re telling them, you’re a critical resource. If you put them on the factory floor and don’t adequately train them, I don’t think they’ll feel like they’re as important as the equipment that you so lovingly maintain.
PhM: What’s important in terms of measuring how training is working?
Ciambrone: We measure both process success—for example, tracking the number of deviations and investigations and how they relate to employees and training—but we also try to measure employee engagement. And one of the most critical questions is, “Do you have what you need to do your job?” We measure that continually. Every year we look at our employees and ask, do they have their basic needs met?
PhM: Is it also more difficult to train workforces that are more flexible, more mobile than they have been in the past?
Ciambrone: The mobility of the workforce I think is a help. You get a more diverse workforce, individuals with a variety of experiences. We’ll hire folks here that are high school graduates, have associate’s degrees from technical schools, bachelor’s degrees, and so on. We’ll hire people who are from allied industries like chemical or device.
We find that to be a benefit. When you have turnover, you learn more about training. You learn how to be more holistic in your approach. So it’s a bit of a challenge, but I look at it as a positive in that you’re able to hire a variety of levels of expertise that can fill a lot of different functions.
PhM: Another thing FDA has been looking at more closely lately is vendor or contract partners, and expecting manufacturers to have a better sense of what those partners are doing and who the people are that are doing it. Has your relationship changed at all with your vendor partners or contract manufacturers in terms of what you need to know about their personnel?
Ciambrone: Our focus on our partners is increasing and evolving. Our Corporate Responsibility program includes stewardship of our suppliers and we work with them across a range of areas, including training. They are required to provide us with the records and training records of all employees. That’s one of the things we scrutinize in audits, but we also want to see that they are progressive in their approach. It’s been reasonably well-received with most of our contract partners because they’ve already been scrutinized by the FDA or because many companies are approaching it the same way as we are, they tend to be pretty cooperative.
They’ve also been interested in what we’re doing with our training, and in some cases trying to adopt some of our practices.
But this is our burden. We have to do it. We have to be able to put a certain level of scrutiny and pressure on them to make sure that they’re doing what they need to be doing to be successful.
PhM: Do you think the additional compliance expectations will resonate with manufacturers and will push them to be more on top of things when they’re monitoring not only their own training but the training of their partners?
Ciambrone: I think so. Certainly, there’s a bit of a wave associated with training. I think the FDA is reacting to what they see in the field, the manufacturer is reacting to what they hear from FDA and their partners. But best practice should change. That’s the whole idea. So as people get better at it, as the bar gets raised, so will performance. It’s not going to happen overnight, but will happen with inspection cycles and as the technology is there to institute a robust training program.
On the other hand, if people are generally pleased with the results, there won’t be as much of an impetus for that particular contractor or firm to make changes. My gut tells me that most companies who have very good compliance generally, and have robust quality, will be less at risk because they have better training programs in general.
PhM: Can you share something you’re doing now related to training that’s somewhat cutting edge, or that would be good for industry to know about?
Ciambrone: We’ve been working with an external training company to do focused and specific pharmaceutical quality training, to really beef up quality leadership and compliance, which is something we take very seriously. The program is module based, with each module geared towards a different aspect of the pharmaceutical industry, such as pharmaceutical chemistry, formulation, analytics, pharmacology, pharmaceutical law, microbiology, etc. At the successful completion of the 3 year module program, students are eligible to receive a master’s degree from an accredited university. That’s a little ahead of the curve in trying to really get people in quality and quality management to understand some of the special responsibilities they have. It’s also a win-win situation for both the company and the individuals given the ability to earn a masters degree through the program. Many individuals would not have the ability to pursue an advanced degree without this level of company support and sponsorship. I believe it has been successful. We took people at intervals away from the work at hand and focused them on understanding things they wouldn’t have gotten from an hour here and an hour there.