Novel Solutions to Closing the Skills Gap
May 19, 2020
In this 4-part blog series, Hélène Pora, Vice President of Technical Communications & Regulatory Strategy offers insight into one of the greatest challenges facing the biopharmaceutical industry today: employee training.
Part Three: Novel Solutions to Closing the Skills Gap
In part one we focused on Acknowledging the Biopharmaceutical Skills Gap and then we reviewed the Industry Training Challenges in part two. Here in part three, we look at creating solutions to close the skills gap.
New Technologies Change the Game
The biopharmaceutical industry is being moved forward by innovations in technology that are helping to streamline processes and achieve new heights. Single-use technologies (SUTs) have been one the greatest enablers of the industry by far over the past decade. However, in an industry that is averse to change, learning how to optimize and leverage traditional technologies with new-school technologies has played a critical role in widening the skills gap.
With SUTs now available for a broad range of applications, including large volume cell cultivation, tank holding, and various downstream purification systems, we see an evolution toward complete single-source SUT manufacturing trains up to 2,000 L working volume. Along with these new manufacturing trains, there are also all the required tubing sets and biocontainer assemblies. But it is not just full SUT assemblies that are driving the industry. Hybrid approaches are also available, integrating different types of technologies to achieve bioprocessing success. And the drive towards continuous bioprocessing is creating a paradigm shift in the industry towards working smarter via automation and data collection and analysis.
All these new approaches to processing have increased the responsibility of the suppliers with regards to providing robust designs and high-quality manufacturing of single-use systems (SUS). On the user side, SUS require various stages of handling and operator interactions, which makes comprehensive current good manufacturing practice (cGMP) focused training programs critical to ensuring that the advances are optimized. Efficient personnel training strategies and collaborative relationships between suppliers and manufacturers can be developed that take into consideration human learning aptitude and ensure efficacious transfer of skills to personnel. The idea is to have lasting impact beyond just complying with regulatory documentation requirements.
Suppliers like Pall Biotech have realized the fundamental responsibility to mitigate additional challenges for manufacturers and have implemented this in product design. At Pall, we continuously improve our design of existing and new systems by engaging a deep understanding of the wants and needs of the end users; this approach is commonly referred to as User Centered Design (UCD).
The International Usability Standard, ISO 13407, specifies the principles and activities of UCD processes, as follows:
1. The design is based upon an explicit understanding of users, tasks and environments.
2. Users are involved throughout design and development.
3. The design is driven and refined by user-centred evaluation.
4. The process is iterative.
5. The design addresses the whole user experience.
6. The design team includes multidisciplinary skills and perspectives.
The goal is to comprehend clearly the end user experience and pain points and deliver design solutions that overcome them. Methods such as Poka-Yoke ‘mistake-proofing’ with colors, number coding, and labeling can help make equipment more intuitive. However, labeling must always be kept minimal and concise.
Regardless of design, training is a critical part cGMP compliance and ultimate success in bioprocesses. Like design, training should be user focused and easy to learn, understand, and apply.
A mix of practical exercises, demonstrations and videos can help with this, with the goal of creating strong recall for the actual application of the methods. To assist in the recollection of the training, quick Instructions for Use (IFU) can provide an executive summary of the training the user received. This can be even more beneficial if the quick IFU can be referred to when using the product (as an instruction label or embedded with the Human Machine Interface [HMI]).
Technology-Based Training for Success
Now more than ever, we see technology playing an irreplaceable role in leading companies into the next generation of bioprocessing. Pall Biotech has made large investments of time and money to optimize technology and deliver products, services, and training systems that support customer goals.
Join us next week, for Part Four: Building Success into Employee Training Programs, where we will explore how Pall Biotech brings together product design and technology for training solutions that ensure success.
View the Biotech regulatory support portal.
Hélène Pora – Vice President, Technical Communication and Regulatory Strategy
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