Relative to your work in pharmaceutical engineering, how have the skills of pharmaceutical employees changed over the years?
There is a need to have a much larger number of people with an understanding of manufacturing as well pharmaceutics and also modern engineering methods at the agency and, to an extent, at the companies. Some larger companies have argued that they actually have the human capital they need for QbD and its just a matter of organizing them differently. However, companies also often tell me that they can't find enough people to hire with the desired multidisciplinary backgrounds. I also see an enormous interest in providing additional training and additional support in some educational areas to current employees. There have been a number of people at FDA who have indicated a keen interest in improving training opportunities to expand the set of operational skills. Thus, there is a very large educational market for training programs that help people with operational skills incorporate more fundamental knowledge of how to do this type of work, especially in multidisciplinary tasks. The pharmaceutical industry is well known for being flexible and very good at adapting to changing circumstances so I'm sure if any of these companies needed to hire people with the necessary skills, they would. The educational process can enormously facilitate that adoption; we can provide a lot of vehicles for incorporating the necessary skill set, whether in-house or through programs at universities.

What are today's manufacturing companies looking for when they say "multidisciplinary"'?
They are looking for people with a much wider integration of multidisciplinary knowledge and skills, including engineering methods, materials science, regulations, pharmaceutical processing, biopharmaceutics, etc. In addition, they would like students to have well-developed communication and business skills. From the educator's point of view, it is quite a challenge to strike the right balance between breadth and depth.

Do these skills include knowledge of computerized systems.
Predictive knowledge is written all over the regulation, whether it is in the language of the PAT initiative, or the definition of understanding a process relative to predictive outcomes. Developing the ability to predict outcomes is by definition developing a model, which could be a statistical model, a full-blown fundamental model such as CFD, or something in between such as DEM. So, yes, there is a significant interest in developing models and some companies have actually created modeling groups in the past few years and have hired people who have training and knowledge in modeling methods. This is a trend. When I visit companies, I meet, much more frequently now, people who are doing different kinds of modeling in house. I don't know how far it will go.

Where were you 30 years ago?
Fernando Muzzio replies: "Thirty years ago I was in Argentina, in high school (10th grade), playing the drums and trying to choose between engineering and medicine."