Despite our industry's advances towards automation and robotics in manufacturing, people remain at the core of our everyday operations. To invest in them, as integral as they are to making our therapeutics, is a classic yet brilliant business decision. I commend various quality leadership throughout the industry when they take the time to actually invest in their people (not just say they do).
I was reminded of this first-hand when listening to a presentation at the recent PDA Annual Meeting by the Global Quality Systems expert from a top 20 pharma company. He was speaking about his company’s implementation of a new educational platform, and underlying the entire presentation was the company’s deep commitment to its people. His tone was genuine, and his words were clear when declaring that “it’s vital to invest in people" and “people are our number one asset.”
I couldn’t be happier to hear these words because they align with the principles for why our team at Quality Executive Partners developed Virtuosi®, the educational platform he was talking about. Operators and analysts are at the core of the pharmaceutical business, and they are the most important stakeholders we have in an organization. They are the ones literally building drug products and ensuring their safe release to the market.
What they learn should directly correlate with their role as an operator or analyst, and it should have real-life application to the skills and techniques they utilize every day. This is why Virtuosi was conceived and created by industry experts who themselves led quality and manufacturing operations as some of the world’s most successful pharmaceutical companies. To invest in people and build their competency is to teach them WHAT they’re doing, WHY they are doing it, and specifically HOW to do it.
Beyond the philosophical foundation to Virtuosi, the structure of this product is also very important to how people relate to the content and use the equipment. People learn in different ways, so we designed the Virtuosi platform with multiple modalities for learning and connecting with each type of learner. Whether it is 2D video lecture content, engaging process checks along the way, or fully immersive, skill building techniques, Virtuosi focuses on what’s most important, and that is people gaining the tangible skills they need to confidently do their job.
During his PDA presentation, the quality expert also mentioned how organizational change management was considered in their decision to implement Virtuosi. He explained that “leading organizational change requires [thinking] of impact to current employees, how to correct current training, as well as future employees” throughout their global operation. Aligning with an educational product that is enduring in its foundational content is important, but also Virtuosi is built on technology that can grow with an organization’s training and education needs. The equipment is scalable, the content is cloud-based, and both can be used anywhere in the world. That is organizational change management at its best.
Finally, as a microbiologist, I know that people can be the greatest source of microbial contamination to the areas in which they work. We saw from the recent release of EU GMP Annex 1, and reinforced at PDA Annual, that it is now mandated that training of persons working in cleanrooms “should include the basic elements of microbiology and hygiene, with a specific focus on cleanroom practices, contamination control, aseptic techniques and the protection of sterile products.” These are not trivial technical principles and teaching them is a very important responsibility. Just telling an operator to do something in a procedure alone is absolutely inadequate, and not the same as explaining its relevance to the safety of the process and product. This new generation of scientists and engineers will ask for better, will demand more opportunities, and I certainly hope the industry will show up for them. With a solution like Virtuosi available on the market, and established pharmaceutical companies already implementing it, I can see the future is promising.
Vanessa Vasadi Figueroa is the QxP Executive Director of Microbiology & Sterility Assurance. During her almost 20 years in pharma quality, Vanessa has built a reputation for her deep knowledge of microbiology and contamination control. Vanessa was one of the co-creators of the QxP Virtuosi learning platform.
