[published 23.June2023 on LinkedIn]
As a veteran in the pharmaceutical industry, one observation that consistently catches my attention is the outdated approach to regulatory training within GxP’s environments [GxP, short for "Good Practices," refers to quality guidelines and regulations in various industries, such as manufacturing or laboratory environments, that ensure product safety, consistency, and quality for the protection of consumers].
It seems as if we've become stuck in a cycle where the primary focus of training is reduced to the reading and testing of Standard Operating Procedures (SOPs). This method is so challenging that even with a solid understanding of the subject, learners often find themselves having to search through the SOP for the precise wording to pass the test. This leads us to question the kind of learner experience that is being created here. Is it effective? Is it engaging? Is it conducive to real learning?
Consider the case of Jane, an experienced scientist at a pharmaceutical company. Jane was tasked with a critical new project that involved working with a new piece of equipment she had never used before. To prepare, she was required to read a 150 page long, detailed SOP and take a test to verify her understanding.
Jane, diligent as she was, spent hours reading the SOP, trying her best to memorize every intricate detail, every specific wording. She then took the test, only to find that it was filled with questions that seemed to be more about the exact language used in the SOP than the operational details of the equipment. Despite her best efforts and her vast experience, Jane couldn't pass the test on her first attempt. She had to retake it, with the SOP open on her desk, searching for the precise phrasing to answer the questions.
In the end, Jane passed the test. But did she feel confident about using the new equipment? Not really. The focus on specific wording rather than the equipment's operation left her unsure of her preparedness. Was this the best use of her time? Certainly not. Could her learning experience have been better? Without a doubt.
The current approach to regulatory training creates a far from ideal learner experience. For instance, consider the emphasis on memorizing the exact wording of an SOP. This focus is so intense that a learner, even with a good grasp of the topic, often finds themselves unable to pass the test without opening the SOP to search for the precise language. Instead of fostering comprehension and competency, the process turns into a taxing exercise of word-for-word recall.
This dynamic creates a dissonance between what is tested and what is truly learned. It's an experience that leaves learners frustrated, as they are tested more on their memory of specific wording than on their understanding of the concepts. It's a system that fails to inspire and empower learners, but rather breeds disillusionment and detracts from the actual goal - true learning.
In light of these observations, we must ask ourselves: Is SOP reading truly training? The answer is a resounding "No". Training, in its truest form, is not about rote memorization or regurgitation of text, but about fostering understanding and facilitating the application of knowledge. It's about nurturing competency, not merely passing a test.
As we navigate the realities of the modern world, we must also evolve our approach to regulatory training. The traditional SOP-centric methodology is not only proving to be ineffective but is also failing to keep up with the advancements in learning and development theory and technology.
We're in 2023, and we can't afford to be stuck in outdated models of learning. It's high time we embraced sustainable learning strategies that align with adult learning principles. These principles emphasize the importance of practical application of knowledge, self-directed learning, and learning driven by a clear understanding of why the knowledge is useful.
One such principle is the need for learning to be relevant and applicable to the job. Adults learn best when they understand the relevance of what they're learning to their work or personal life. This means moving away from generic, one-size-fits-all training and towards more personalized, job-specific training.
Another principle is the respect for the learner's prior knowledge and experience. Each individual brings a unique set of experiences and knowledge to the learning process. Training should build on this existing knowledge base, rather than treating every learner as a blank slate.
Furthermore, we must acknowledge that adults are self-directed learners. They prefer to take control of their learning process. Hence, providing opportunities for self-assessment, and enabling learners to identify their learning needs and chart their own learning paths is crucial.
A shift towards more interactive, engaging, and learner-centered methodologies can greatly enhance the learner experience. It can increase knowledge retention, build more competent employees, and ultimately lead to improved regulatory compliance.
By adopting these principles and strategies, we can transform regulatory training from a dreaded task into an empowering and enriching process.
In today's digital age, where information is at our fingertips and AI technology continues to make strides, the creation of bite-sized learning experiences is not just a trend – it's a revolution. These brief, focused learning units, also known as "microlearning", can provide just-in-time training that is easily digestible and immediately applicable.
Imagine a learner needing to understand a certain procedure or regulatory requirement. Instead of trudging through a 50-page SOP, they can access a 5-minute, targeted learning module that provides the essential information they need. This approach respects the learner's time, fits into busy work schedules, and allows for knowledge to be quickly applied in real-time situations.
Moreover, advancements in AI technology are making learning more personalized and adaptive than ever. AI can analyze a learner's progress, identify areas of strength and weakness, and tailor content accordingly. This means learners are not just consuming information; they're engaging with it in a way that's relevant to their unique learning journey.
One innovative application of AI in training is the use of digital twins, virtual replicas of physical systems or processes that can be used for simulation and analysis. In the context of regulatory training, digital twins could simulate complex procedures or protocols, enabling learners to gain hands-on experience in a risk-free environment. This not only enhances understanding but also allows for the safe exploration and mastery of SOPs.
Furthermore, AI can facilitate spaced repetition, a powerful learning technique that involves revisiting information at intervals over time. This method, proven to enhance memory retention, can be seamlessly integrated into bite-sized learning experiences.
In essence, the integration of bite-sized learning, AI, and digital twins can transform regulatory training. It can turn a typically tedious process into a dynamic, engaging, and highly effective learning experience. Let's harness these advancements to make regulatory training more impactful and enjoyable.
But why stop there? Imagine a world where learning is seamlessly integrated into the flow of work. Through effective knowledge management, we can create environments where learning is not an isolated event, but a continuous process. This approach keeps knowledge fresh, reinforces learning, and supports the application of new skills and concepts in real-time. Read my previous article to learn more on how Knowledge Management can support Training and Learning. Click here to read.
The pharmaceutical industry, like all industries, is on a path of constant evolution. The current state of regulatory training, characterized by rote memorization and compliance-focused tests, falls short of the dynamic and rapidly changing landscape of our times.
However, the potential for transformation is immense. By embracing new approaches such as bite-sized learning, AI technology, digital twins, and integrating learning into the flow of work, we can revolutionize the learner experience. This shift will create a world where regulatory training not only satisfies the requirements but also inspires, engages, and truly educates.
Let's remember that the goal of regulatory training isn't just about ticking boxes for compliance; it's about equipping our professionals with competence. It's about nurturing a culture of continuous learning that elevates the entire industry.
In this age of technological advancement, we have the tools at our disposal to make this paradigm shift. Let's seize the moment and usher in a new era for regulatory training in the pharmaceutical industry.
#RegulatoryTraining #PharmaceuticalIndustry #GxP Hashtag #GoodPractices #SOP #AdultLearning #BiteSizedLearning #Microlearning #AIinEducation #DigitalTwins #ContinuousLearning #LearningAndDevelopment #KnowledgeManagement #TrainingInnovation #RegulatoryCompliance