Tenth grade. High school. Speech class. Six words that, to most of us, including me, bring back various thoughts and emotions. Maybe one of those emotions is “fear”? But what if I told you that back then, and still today, you and I both have everything we need to be able to speak in front of a group of a thousand strangers? We are able to manipulate our mouth and breath in such a way as to generate words in a certain language.
But is “ability” or “competency” the desired outcome?
What is Remote-Based Training (RBT)?
Organizations are rapidly pivoting to web-based modules for training content to allow on-demand access, largely as a resource optimization tool--and that was before COVID-19. Now, training employees who reside literally anywhere, with the greatest degree of flexibility, is a business and compliance imperative.
Web-based training, or “WBT”, is quickly morphing into what I call remote-based training, or “RBT”. RBT is training that is digital, with synchronous and asynchronous timeframes, virtual Instructor Lead Training (vILT) or self-directed, and outside of typical environments (think a kitchen table rather than a lab bench).
How does remote-based training apply to regulated Life Science teams?
How does this sync with the objectives of training and training management, especially in the Life Sciences? Before we can answer that, we have to look at the current standards for training. We know that training in the regulated space of pharmaceuticals, medical devices, et cetera, is aimed at achieving an outcome where the person is deemed qualified to perform a task.
More often than not, however, companies view training as an event, an instance, or maybe a list of tasks to be completed before a person is allowed to do the task on their own (we cleverly use the term “qualified” – more on that some other time…). After all, auditors and regulatory agency inspectors often only ask for a training record or summary report as evidence of qualification.
Yet most 483 and warning letter citations imply that lists of checked boxes aren’t sufficient to prevent instances where regulators deemed training inadequate. Real-time competency seems to be in question, which has little to do with a simple list of training requirements.
But if that list is masterfully constructed, along with each item in it, ability and competence become dual outcomes of a more robust – and effective – training process.
Overall, the evolution to RBT in light of “competency over ability” holds many advantages, not the least of which is even greater flexibility and access. But like my spiritual advisor tells me all the time, for every “yin”, there is a “yang”. Suppose we approach RBT as the “be all, end all” for training, like that list of SOPs.
In that case, we stand to fall short of the ultimate goal of a GxP training program, which, again, is to build competency within our staff. We have several fewer risks to worry about when it comes to evaluating our products against compliance-based regulations.
Imagine trying to build a house with only a hammer. You’ve got a great tool that works well, until you end up having to cut a piece of wood or install a light socket. So, if we approach RBT from the perspective of it being one of many tools in our training toolbox, and understand what it does well and what it doesn’t, then we’re more likely to build a solid, sustainable training program.
How can RBT help meet GxP training objectives?
Let’s start with what RBT is good at:
- Delivering information clearly, consistently and concisely to many individuals, especially around concepts, process/procedure/system overviews, general expectations, and describing what resources and tools are available for support.
- Building on any pre-work that is done by the trainee, included self-directed training like reading a procedure, policy document, regulatory guidance document or industry white paper.
- Enabling trainees to receive and complete their training on-demand, based on their current priorities and needs.
- Enabling on-demand opportunities to refresh and/or reinforce concepts.
- Posing pre-defined, general scenarios and other immediate knowledge checks to ensure a certain level of knowledge transfer prior to granting completion credit.
Now, let's look at what challenges RBT can present?
While these are not absolutes, items offered below can be addressed to different degrees based on the complexity of the RBT module itself.
- Fostering human interaction and feedback, which foster trust and confidence more so than without that interaction.
- Addressing the multitude of “what if” scenarios or situations that may be important for the trainees’ understanding or application.
- Quickly adapting to changes. Adding a different, new or potentially better example requires revising the RBT module. Then you have to answer the question: do previously trained participants require training on the update? And that isn’t as simple as it seems.
- Providing multiple opportunities to practice in the actual environment where the work will be done, which is key to long-term retention and competency.
- Evaluating on-the-job proficiency and competency in handling real-life situations. These inherently rely on human-human interaction and some element of observation or evaluation beyond a quiz.
The 5P Framework for RBT
In order to build competency, an individual must focus on two aspects of learning – expanding their knowledge and developing skill(s) required to apply that knowledge in real life. But there’s more to it than that. Long-term competency is only achieved through practice, feedback and development of critical thinking patterns that are relevant to the particular task or topic. And ultimately, the evaluation of those skills back on the job falls to another human being. In order to decide what could be delivered through RBT, and whether it will be effective, consider the following actions.
Perform a needs analysis.
You have your content and objectives, as well as the reasons why the content is important. Now break down that content into categories of “Need to Know” and “Nice to Know”. Good news is that you get to decide. The bad news is that although many have tried to define and clearly differentiate these two, I find it always comes down to preference and trial-and-error. You’ll hear about it if it’s either too much or not enough, so accept that as one of your outcomes and make adjustments based on the feedback you get.
Start smaller than you think you should. Design the RBT to cover the need to know information, and describe where to go for more (including the nice to know information).
Run a few pilots to validate your approach. Seek out a small but highly diverse group across your intended audience to participate in the training. Include people who you think will be difficult to engage or have very different opinions and thoughts, then gather as much feedback as you can. They will be appreciative for being asked, and you’re one step closer to engaging them positively.
Prep your audience.
Have the manager prepare the intended audience with a pre-training message. This should discuss the topic, objectives, applications to the trainee’s work, intended outcomes from training process and build initial confidence in trainee. This is best done face-to-face, so cue up the Zoom meeting window again! These points could be delivered using any number of formats, including email.
Follow-up with human interactions that focus on application, reinforce expectations, and illuminate and answer concerns or questions. These can be led by a trainer, experienced subject matter expert (SME) or a manager, and can be 1:1 or in a group. Keep in mind group dynamics are wonderful at fostering teamwork, collaborative problem-solving and trust in people to whom they can go to if they need further support.
Let’s look at how the RBT-framework might look in practice with a GMP Training example:
Let's say a manager communicates that GMPs apply to the group’s work and why they are important. The manager then introduces the RBT, communicates expectations and desired outcomes, discusses ways for trainees to be successful based on learnings from the pilot sessions, and specifies a completion due date.
The individuals on the team can then decide when to complete the training and do so on their own, giving them more flexibility.
Once the team has completed the training, the manager, QA representative and/or trainer meets with the participant(s) afterwards to describe/reinforce how the material applies to specific situations, talks about critical thinking and decision-making related to the topic and the group’s work/tasks, providing environment for defining what decisions people can/should make on their own and when to escalate and to whom.
This also gives the manager immediate feedback on the RBT’s effectiveness and now knows where additional focus is or is not required.
Team continues to discuss the topic periodically/as needed in group meetings or other settings to reinforce and refresh, building long term competency, confidence and improved performance.
An investment of time for a bigger return
“But this all takes time, and the RBT was supposed to decrease the amount of time and/or the number of training sessions we all need to complete! How is this better?” Let’s take a look.
Assuming the average GMP training class is scheduled for an hour, a typical participants’ time allocated to completion would be about 90 minutes, which includes the class itself, registering for a session that works for their schedule, then about 20-25 minutes of total travel and disruption time.
If a stitch in time saves nine, then a well-structured RBT module is definitely a well-placed stitch in your training program. Delivering need-to-know information and beginning to illustrate real-life applications with RBT will take half the time of that hour-long classroom session.
If we just focus on breaking even, we now have 60 minutes available to use for applied learning, reinforcement and connection that is specific to a smaller group of people. The outcomes are significantly better while allocating the same 90 minutes of time, and often less.
You might be thinking:“Like everything else on my plate, this makes sense. But how in the world do I actually do all this?”
Three key tips to ensure effectiveness and efficiency with RBT
First, include elements to highlight human-centered engagement
You don't need a lot to get started with RBT, though there are a lot of great e-learning resources and research you can learn more about.
To get started, let's say you use PowerPoint or Google slides, you can include the following elements in new presentations or even updating current trainings (all of which are not as time-consuming or expensive as you might think).
- Structure your training to include interactions, scenarios, situational or directed learning based on answers to guiding questions or quizzes.
- Use real human voices. AI voices are getting better, but can’t relay true emotions such as humor and empathy, and aren’t able to emphasize key points with inflection, pace or tone. Voiceover talent doesn’t have to be expensive, but does have to be professional in order to maximize effectiveness. You want your trainee to “feel” as often as they think, because that increases retention, too, by stimulating more places for information to “stick” within the brain.
- Including music and/or engaging (yet appropriate) color schemes will add a professionalism that your trainees will pick up on, further reinforcing the content as important. (Note: just be sure that you’ve obtained a Creative Commons license or licensed the music, or if you have a hidden talent, create your own soundtrack).
Second, "chunk" your training concepts
In today’s dynamic work environments, attention spans are shorter. Flexibility is a necessity. And this kind of training can be and often is viewed as a benefit, enabling people to continue developing and growing within an organization, largely on their terms. The use of technology is now expected, especially by younger workers. Engage them on their terms and you’ll be more likely to achieve your desired outcome.
Most importantly, delivering content in smaller, more frequent chunks has long been known to drive up retention and successful application. Today, we call it microlearning. Constructing your RBT modules to include two or three related segments around key points, each segment being about 6-8 minutes long, you’ll keep things manageable and your learners engaged. And with the advent of virtual reality-based training, even complex techniques can be taught, and better yet practiced, in any environment where there’s sufficient space to move around. Imagine practicing aseptic technique while in your t-shirt and shorts in your living room? As amazing as that sounds, it’s a reality today in this remote working environment.
The blended training approach and microlearning framework are backed up by current research around how adults best build competency. I’d cite them, but there’s literally too many sources to list here. If you want more information, check out the Association for Talent Development, the most prominent professional association for the Training field.
Third, be the go-to person (or find them)
Remember the human interactions that are required for retention and competency? Following up the RBT with Q&A and application discussions also reinforces the topic as important, and subliminally cements you as the go-to person on the subject. If you’re feeling a bit nervous about this, have a subject matter expert (SME) facilitate the session or there with you.
I can’t tell you how many times people have sought me out for answers to questions following training classes instead of their immediate supervisor, manager or SME, especially around how the content applies to a certain situation or problem they’re currently having. We call it familiarity bias (also known as the mere exposure effect). Take advantage of this phenomenon to position the right people as the “go-to” people, and as a way of improving your relationships with your staff.
Ready to implement RBT? Don't forget...
So you’re ready to hire a team of a dozen Training professionals to get started, right? While I appreciate and share your enthusiasm, I’ll let you in on a little secret. You don’t need a large team to implement a solid RBT program. Start small and learn what works and what doesn’t in your environment. Remember, great training programs aren't built in a day.
Many organizations, including those with training departments of one, are developing RBT internally with easy-to-use, relatively inexpensive tools, and software. If you aren’t able or interested in the D-I-Y approach, a slew of vendors are available to provide off-the-shelf and/or customized solutions, and often for less than you might think. But like that shiny vehicle at the used car lot, buyer beware. Make sure the vendor understands you, your business processes, your unique needs and challenges. They should talk in terms of competency and effectiveness, and ask how you envision the RBT modules complementing your existing and future training.
After all, you’re no longer chasing a checked box, you’re leveraging a proven methodology for enhancing your team’s ability to perform at a high level, solve problems and reduce risk, all by fostering opportunities for critical thinking, trust and connection. What could be better than that?
So, remember that 10th grader that I told you about that was scared out of his Dockers? Well, what started as a clunky, nerve-wracking 10 minutes of barely-audible sounds coming from the mouth of that pimple-faced kid, is now a natural comfort level in having a conversation with hundreds of strangers at the same time during professional meetings and conferences.
And trust me, that didn’t happen solely because I read an SOP or watched a video and then walked up to a podium...
Do you want to learn more about maximizing your remote training? Join us on November 19th from 12:00-12:45 for "Training Beyond Standard Operating Procedures," an interactive forum, including best practices for training remotely for Life Science companies.
As an independent consultant, Mike Kent helps organizations become more effective, efficient, and compliant by optimizing the way people learn and perform their work. He has over 29 years of training, quality, and technical expertise in regulated environments across the pharmaceutical, medical device, biologics, and diagnostic industries. Blending this experience with a strong passion for training, knowledge management, and human performance, Mike is able to enhance and help sustain a robust quality culture based on good decision-making and engagement. A drug development chemist turned quality systems professional, he specializes in optimizing the interface between people and their work environments.
Mike received his Bachelor of Science degree in Chemistry from Colorado State University, where he first started teaching and conducting pharmaceutical research.