Stephanie Gaulding, CQA CGP, Managing Director, Pharmatech Associates
The fast-paced, highly regulated pharmaceutical industry requires companies to have a well-trained and competent workforce. Traditional training methods with their “read and understood” and formal instruction, are no longer sufficient in building capabilities and deepening knowledge within our employees.
The traditional “70-20-10” model, which states that 70% of learning comes from on-the-job experiences, 20% from interactions with others, and only 10% from formal instruction, has also changed. With the rise of technology and social learning platforms, informal learning through interactions with people has become more important than ever.
Adults learn through practice and application rather than just reading or listening. This is true in the pharmaceutical industry, where practical skills are essential for performing assigned functions. Regulatory requirements also require that companies demonstrate their employees have the necessary education, training, and experience to perform their duties effectively.
Fortunately, evolving technology brings new ways to help employees practice and hone their skills before performing them in real-life situations. There are tools that can greatly enhance traditional training methods and provide a comprehensive learning experience for employees.
This article discusses the emerging trend toward competency-based learning and how it is adapted to the modern learner. Competency-based learning builds on formal training and hands-on experience with an increased emphasis on social learning that improves business all around.
Understanding Competency-Based Learning
Essentially, competency-based learning is a structured approach that focuses on developing specific skills, knowledge, and behaviors essential for success in a job or role. Unlike traditional training methods which assess knowledge or skills, competency-based learning focuses on outcomes to ensure learners demonstrate proficiency before advancing. This is done by defining the specific knowledge and skills necessary for an employee to successfully perform a role or task. A competency-based approach significantly differs from current approaches, where employees often memorize information for quizzes or tests at the end of a training session.
For example: instead of focusing on which procedures and batch records need to be read to blister pack tablets or capsules into their required packaging configuration, defining the training needs starts with questions about the desired outcomes (results) for performing this task or operation, then breaking those down into the supporting knowledge and skills that need to be taught to an operator. Training is then designed in a manner where the operator progresses at their own pace and demonstrates the practical application of their skills and knowledge.
Addressing Adult Learning Needs
Adult learners bring a wealth of experience, diverse backgrounds, and specific learning preferences to the training environment, requiring an approach that caters to their individuality, and this can create frustration for experienced employees because current training programs do not take this fundamental difference into consideration. Competency-based programs can be designed to accommodate varying levels of prior knowledge and experience, allowing employees to build upon their existing expertise and fill in knowledge gaps relevant to their specific roles.
Adult learners also have varied preferences for the way that they learn – some like to read, some like to listen, some like to watch or observe someone else, and others can only really learn by doing a task or activity. Competency-based learning programs incorporate a variety of methods to build knowledge and skills and allow an employee to spend time in their favorite learning method while still working towards a set of desired outcomes. Videos cater to auditory and visual learners while providing transcripts that allow avid readers to access the same content easily.
Another consideration for adult learners is the integration of real-world relevance and application into what they are learning. While many modern training programs connect with this adult learning principle, it is often relegated to a classroom environment or a scenario with options in a computer-based training course, neither of which provides true experiential learning. Competency-based learning programs combine hands-on experiences with social learning opportunities, driving a learner-centered approach where employees progress at their own pace and focus on areas where they need to improve.
The Importance of Social Learning
Simply put, social learning is learning with and from others. If you think about it, social learning has been around as long as humans have – we learn best when connecting with others and sharing knowledge and experiences. One of the key benefits of social learning is the ability to tap into the collective expertise of the entire workforce.
In recent years, this type of learning has moved into the digital space. Today, through discussion forums, virtual communities, and knowledge-sharing platforms, employees can learn from each other’s experiences and gain insights that may not be covered in traditional training materials. Peer-to-peer knowledge-sharing enhances learning outcomes and fosters a sense of community and collaboration within the organization.
Adding peer mentoring and coaching programs into competency-based training initiatives means learners receive personalized guidance and support as they strive to develop and demonstrate essential competencies through what is basically social learning. This mentorship approach enhances the learning process and nurtures a culture of knowledge exchange within the pharmaceutical workforce.
Technology Support
Learning management systems (LMS) are the foundational technology platform for any training program in the pharma industry. They help manage training content, track learner progress, and generate detailed reports on the effectiveness of training initiatives that are still necessary for competency-based training programs. Adaptive learning platforms, augmented reality solutions, and virtual reality simulations are useful technologies that can further strengthen a competency-based learning program within any pharmaceutical company.
Let’s start with adaptive learning platforms. Adaptive learning platforms allow for a flexible learning experience centered on where the employee is in terms of knowledge, confidence, and experience. These tools are dynamic, adjusting the content based on the learner’s progress, allowing users to move quickly through concepts they are familiar with and reinforcing concepts they are struggling to grasp. Adaptive learning platforms can be integrated with many common LMS solutions and support competency-based learning programs by allowing learners to identify and focus on gaps between their existing knowledge and skills and continually assess their progress toward achieving the defined outcomes for a specific competency or learning area.
Augmented reality and virtual reality are often used interchangeably but are not the same. Virtual reality simulations provide an immersive learning experience by creating realistic scenarios in a completely virtual environment. Augmented reality works by adding digital elements to real-life environments, usually through goggles or glasses, that a learner can interact with. Both simulation methodologies allow learners to practice skills, such as maintaining a tablet press or responding to equipment errors, in a safe and controlled setting and support transferring their learning to real-world situations. The integration of virtual reality and augmented reality technologies is poised to revolutionize hands-on training in pharmaceutical labs and manufacturing facilities.
Moving to Competency-based Learning
As competency-based learning continues to shape the future of training programs for the pharmaceutical industry, it presents opportunities and challenges. One of the biggest opportunities is that it enables pharmaceutical organizations to quickly pivot and address emerging skill requirements. As the industry undergoes rapid advancements and transformations, the ability to adapt is paramount: moving to competency-based training programs creates pathways for continuous learning and upskilling our employees, so that employees and organizations can rapidly adapt to new technologies or requirements. This lifelong learning approach fosters a culture of innovation and adaptability and positions pharmaceutical companies for sustained success in a rapidly changing environment.
Another significant opportunity is the potential for more targeted and impactful training, where pharmaceutical companies can tailor learning experiences to the precise needs of the employee, ensure that they acquire the specific competencies required to excel in their roles, and avoid excessive or irrelevant training requirements.
Integrating with the Status Quo
However, adopting competency-based learning in the pharmaceutical industry also poses certain challenges. One challenge is integrating competency-based learning into the existing training infrastructure within pharmaceutical companies. This requires first a shift in mindset and then allocating resources and support for the design, implementation, and evaluation of competency-based training initiatives. Historically, our industry views demonstrating our staff are qualified to perform their jobs means that we have documentation that they’ve read every document related to that activity, been through some form of assessment, and, if needed, completed some form of formal training.
Once an organization has the right mindset to implement competency-based learning, it can develop and implement a competency-based framework. This requires careful planning, beginning with standardization and assessment of competencies across diverse roles within the organization and evaluation of existing technology for capabilities to support the shift to competency-based learning.
Another big challenge is the need for robust assessment and evaluation mechanisms to measure learners’ proficiency in specific competencies. Simple quizzes are not sufficient in a competency-based learning program. Developing valid and reliable assessment tools that accurately measure the proficiency levels of professionals in targeted skill sets is essential for ensuring the quality and credibility of competency-based training programs.
Conclusion
Competency-based training may seem like an easy sell, but bringing this type of learning model to life within a company can be difficult and take time, often multiple years. For example, while it’s important to remember that every learner brings their own learning style to the table, most people learn better when they can connect with others and leverage their experiences and expertise to help achieve their goals. Competency-based learning programs take advantage of this natural phenomenon because they integrate collaboration, emulation, and skill-sharing into the curriculum and within the workforce. Such programs create more flexible training schedules and curriculum content that is tailored to individual learners. However, despite the potential benefits, there can be challenges associated with implementing honest, open-ended training initiatives that center on real-world application and social learning. The top challenges associated with implementing competency-based training include budgetary constraints, a rigorous on-time training compliance schedule, a workforce that is unwilling to be flexible, and a sense of timidity within managers and leaders when it comes to adopting new methods and tools. Overcoming these challenges often drives longer implementation timeframes than initially planned. For the pharma industry, when we shift our mindsets away from a documentation-centric focus to a learner-centric focus as competency-based learning does, then we develop qualified employees able to perform certain roles with specific outcomes.
Author Biography
Stephanie Gaulding, Pharmatech Associates’ managing director, has over 25 years of experience in the pharma, biotech, medical device, and related life science industries developing and delivering sustainable quality management systems that assure compliance with global regulatory requirements and industry best practices. She is an ASQ certified quality auditor and ASQ certified pharmaceutical GMP professional. She holds a M.Sc. in Biotechnology from Johns Hopkins University and a B.Sc. in Biology from Virginia Tech.