I clearly remember my first job in the industry following graduate school. One of the things that impressed me about my employer (Abbott Laboratories, a large multinational pharmaceutical company) was the broad spectrum of training that they offered to employees. Two things struck me: firstly, they offered us the opportunity to take time from our schedules to attend any of the training that was offered within the company, and secondly, they had a wide variety of training courses available.
There were 2 types of training that I recall clearly. One was information about the diseases we worked on, and the other was related to ancillary parts of our jobs, such as intellectual property protection and safety.
At the time I joined, I was part of what soon became the Hepatitis and AIDS Business Unit, which was part of Abbott Diagnostics. I was fortunate to be part of the team that brought to market the first commercial product for screening donated blood for HIV, a product that, within 2 years, had sales of over $200 million dollars. In the early 1980s, this was a lot of money, especially for a diagnostic.
It was very interesting for me as a freshman engineer to learn the science of the biology and virology that underlay our product development work and how this impacted the patients who used our products. This early connection to patients has benefited me throughout my career as I have focused on bringing products to market in order to relieve suffering among patients. One of the joys of working in the pharmaceutical industry is that many of my colleagues also gain an emotional and spiritual benefit from helping the patients we serve.
Now, over 30 years later, I spend a lot of time auditing GMP manufacturing and GLP testing facilities. I always delve into training for 2 reasons. One is that in every FDA inspection in which I have participated, the inspector has always asked about employee training. The second reason is that the review of the training program is an easy way to establish the level of general compliance of the organization.
I’d like to share with you some of the challenges I see among the companies I audit.
There are 2 primary goals for training programs: 1) ensure employees are trained and 2) demonstrate the same to the inspector. For many companies, the second goal is much more difficult. That is, while it may appear the company has a good training program, they have difficulty in proving this.
So the question is: What is it that we need to demonstrate in order to satisfy the inspector or auditor?
I remember an inspection in which the FDA representative opened a batch record, pointed to an employee’s initials, and asked the company to demonstrate that this employee was trained on this manufacturing step. This is a very simple question to ask, but I am surprised how difficult it can be for some companies to answer. The response requires that we have a means to trace back to the employee’s training records and confirm when training took place (namely, prior to the employee filling out the batch record) for that process.
Every training program needs to address this fundamental issue: Was the employee trained for the work she did and is that training documented and readily accessible? As we build our training programs we must keep the end in mind. We must demonstrate that our employees are trained on the work they do.
So this satisfies the second part of the goal. The first part may be more difficult, namely, ensuring that our employees not only go through the training program, but also understand the material and incorporate it into their work practice.
Various different cultures have different behaviors that influence training effectiveness. I am privileged to live and work in China, where the learning style is different from other regions. For many years, I provided training in the US on general GMP and on biopharmaceutical manufacturing. I enjoyed this training because of the interaction with the students who had different backgrounds and points of view that enriched the course material. For example, when speaking about aseptic processing, I would draw on the experience of a student who had worked on an aseptic line to explain the rigors of working in grade A and B areas. These students had an enthusiasm and passion when describing their work that made the description of their experience very believable, drawing the entire class into the feeling of the workplace.
In contrast, I remember my first training experience in China. I was invited by a former colleague to provide GMP training for his staff of 50 workers. I prepared slides that in the US would take an hour to present, but in China they only took 20 minutes, and that was with a translator speaking every other line! I reached the end of the slides and thought, “Now what am I going to do?”
In some cultures, students don’t volunteer. There may be multiple reasons for this. Sometimes they don’t want their colleagues to think they don’t know the answer so they won’t ask a question. Sometimes they don’t want to appear pushy or aggressive or as knowing all the answers. Sometimes the case may be that the educators are held in an exalted position, and the student feels that questioning the teacher would be considered disrespectful.
Later when I taught other courses at this same company, I would plant questions among people I knew in the audience, with instructions that they must ask these questions in order to get the Q&A session rolling. Not every organization is like this and I recall another company where the question period went way over time because of the number of questions. I still do not fully understand what was different at this second firm.
One of my favorite training experiences was on the subject of how to deal with inspectors, which I conducted at the site of a large parenteral manufacturing facility with 200 people assembled in the cafeteria. I asked for a volunteer for some role-playing and of course, no one offered. (I had hoped for a volunteer so that I would not embarrass someone shy.) So then I asked for the manufacturing supervisor to identify herself and asked her to call on one of her operators. The concept I was trying to get across in this exercise was that when you don’t know the answer, you should reply, “I don’t know.” The first time I asked the question—which I knew was hard and I didn’t expect him to know the answer—he started rambling on in an effort to avoid a direct answer. I stopped him and reinstructed that when he doesn’t know the answer he should reply, “I don’t know.” I asked another obscure question, and he started rambling again. So I stopped him and reiterated the right response. This time he caught on and when I asked the question, in a bold voice he replied, “I don’t know, sir!” Everyone laughed. Mission accomplished.
Training is something we do for a reason. It is important to our employees, to our company, and to our patients. It is not something we can ignore or do half-heartedly. I hope we can all be successful in the training we give and receive.
Scott M. Wheelwright, PhD is co-founder and principal consultant at Complya Asia, a consulting firm located in China that supports companies in Asia with Quality Assurance and cGMP compliance. Complya provides boots on the ground for companies running projects in Asia, including sourcing of drug substance, API, and testing, along with audits of vendors that provide GMP and GLP services.