Kent Malmros is senior director of training at Veeva Systems. He has spent the majority of his career delivering technology-enabled training solutions to life-sciences companies and has held leadership positions at companies that include AdMed, ClearPoint (Red Nucleus), and UL EduNeering (UL).

Kent Malmros

Two scientists in white lab coats and gloves developing new effective drug together. Serious young student trainee with clipboard making notes and talking to senior professor in university laboratory | © Studio Romantic. - stock.adobe.com

The number one reason biopharma companies receive a warning letter from FDA is not having procedures in writing or fully followed signaling an opportunity to improve employee training practices (1). The training matrix can be the unsung hero of a well-defined good practices (GxP) training program because it ensures the accountability and traceability required by regulators.

Every company tries to deliver effective training by getting the right content to the right people at the right time to ensure qualification, job readiness, and professional development. Establishing a GxP training matrix and a strategic plan can help, but without a single programmatic approach to building a matrix, many tend to lean on traditional processes that haven't worked well in the past.

Industry leaders at the forefront of improving learning outcomes have shared insights on why every company can benefit from developing a training matrix and best practices to get started.

The training matrix and training plan are interdependent, each feeding off the other to support employees and ensure they can meet all requirements. Understanding the role each play is critical to developing a comprehensive and compliant learning program.

Training matrices include a collection of all the curricula that employees need to complete for qualification to perform a job. The training plan defines the order in which courses should be taken, how they will be delivered, and key deadlines for completion.

"A training matrix provides the overarching strategy for what a particular group or organization needs to do to qualify an employee," said Christian Torstensson, director of learning and development at Sanofi. "The plan details how to execute that matrix" (2).

Developing a training matrix should be a priority for all companies, large or small. Unfortunately, a frequent practice across the industry is putting all existing training plans into a learning management system (LMS) and using it as the default matrix. This approach provides a quick fix but can increase risk when deployed without a defined strategy.

To address this challenge, thoughtful strategies around how the different training plans work together should be created. Additionally, looking at the plans holistically can help drive efficient qualifications practices and lower the risk of non-compliance.

Understanding regulations to streamline employee education

A poll of training and employee development executives found that 93% take a role-based approach to building curricula (2). While role-based training can provide a solid blueprint to cover all education needed for core compliance, it may not give organizations the best path toward extended qualifications and personal development of employees.

) Title 21, "each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience" to enable them to do their job (3). With such broad guidance on training, companies adopt numerous strategies to drive job requirements and prove completion.

"The regulations don't provide details about how companies need to conduct qualification," said John Constantine, senior vice president at Orchestrall. "Pick the right matrix or method that fits best within the organization to ensure inspectors can confirm the company has done what is in its documentation. Stick with your matrix, and don't deviate from it" (2).

A usual pitfall is designing an overly complex matrix to meet regulatory requirements. Increased complexity leads to processes that are hard to track and data that are not unified. FDA's guidance is simple, so push that through to your strategy. A simple matrix incorporating governance and adherence is an excellent approach to apply.

To assemble a matrix, it is imperative to develop a logical hierarchy and structure driven by individuals involved in learning and development. The business function should own what an employee needs to be trained on, and the training department handles the execution.

"It is imperative to have a good solid structure and management within the individual departments that ensure that people are trained on what they need," said Nicole Donovan, former director of organizational development at TOLMAR (2).

Next, identify buckets for training and define them. This step could include qualification, role, or skills-based training. Defining buckets helps people understand why they received a request to complete a training assignment. Ensure they don't overlap and make it easy for staff to choose the required courses by answering simple questions.

"Figure out what those buckets are and make it so people can answer simple questions like, are you based at this site? Are you in a GMP role? Do you work in a cleaning space?" adds Torstensson. "Those employees will be much more successful getting assignments completed."

Taking this approach defines what you need on the most basic level. Be flexible with the framework to determine what works and what doesn't. Talking to individuals can provide a deeper understanding of their job requirements and how those fit with FDA guidance. Ultimately, the process helps learning teams match individuals, teams, and departments with the training they need to perform and ensure qualification and competency.

Establishing real-time visibility with a digital approach

A digital learning management system (LMS) can help provide process rigor by allowing team leaders to tag training by location, site, department, and facility while adding recurrences based on requirements. This helps to bring together data all in one place, making it easier to analyze information, identify patterns or missing assignments, and prove compliance.

"Many companies try to fit the old way of doing things into their digital LMS, which is not the right way to go," says Constantine. "The path forward is to take the best of how things are done now, with a training matrix, and adapting it to what the system is best at doing."

When evaluating an LMS, look for solutions that offer:

assignment mapping based on industry, job functions, departments, or roles

automatically triggered training tasks based on events such as approved content changes and CAPA plans.

"With a digital system, we know when people are completing training on time, if they are late, or not completing it at all," adds Donovan. "These are big milestones we need to know to improve our processes and ensure staff are qualified to perform their jobs. A digital system helps eliminate all the unknowns of using paper."

Companies that can build a training matrix and an execution plan are on the fast track to ensure audit readiness. Establishing common terminology and understanding the relationships across definitions, processes, systems, and delivery are key. Keeping each aspect simple helps make it understandable and implementable in the long term.

At times, training leaders are battling each other instead of helping. Not intentionally, but just because they're trying to execute every day without context. A training matrix can provide alignment across leadership, departments, line managers, and employees, delivering clarity and accountability.

Companies can remain a step ahead by establishing a strong GxP training matrix and pairing it with a strategic plan and LMS. But all three support each other. No one alone can transform training operations, as Torstensson pointed out. "When organizing training to see trends and consistency, the LMS shouldn't drive the process. Far too often, a system is selected because, in some way, the thought is it will magically make the training program into something that it isn't," he said (2).

Best Practices for Developing and Maintaining a GxP Training Matrix

Kent Malmros is vice president of training strategy at Veeva. He has spent most of his career delivering technology-enabled training solutions to life sciences companies and has held leadership positions at AdMed, ClearPoint (Red Nucleus), and UL EduNeering (UL).

Articles

Companies can benefit from developing a single programmatic approach to a GxP training matrix.

Quality's Unsung Hero: The GxP Training Matrix

It is no secret that staff training remains a weak spot in many corporate strategies. In 2017, 30% of the 40 warning letters that FDA issued for data integrity deficiencies directly referred to inadequate training or training requirements (1).

	A number of challenges prevent life-sciences companies from developing more effective training programs. One major problem is the way training-related data have been traditionally organized. For example, most pharmaceutical and biopharmaceutical companies use one system to manage standard operating procedures (SOPs) and other knowledge-management documents, and a different system to manage training. Ideally, the two areas should be connected, or a barrier will be created between activities that should be closely aligned.

	For example, consider the specialty pharmaceutical company Tolmar, which had built a custom application to manage and track compliance-based training requirements, but used a cloud-based system to administer various other types of training. The company’s in-house learning management system (LMS) required extensive configuration and integration, as well as ongoing validation support.

	“We have around 1600 documents that 700 employees across the organization need to be trained on. Managing this workload across two applications-our cloud-based document management system and in-house LMS-is complex and requires a lot of overhead,” says Joe Miller, Tolmar’s vice-president of information technology.

	A similar lack of alignment is often seen between training systems and corporate business objectives, which can make it difficult to link training outcomes with concrete goals such as reducing manufacturing-related deviations or other quality events. Rather than viewing training as a corporate expense, managers should be able to see how effective training programs directly influence critical quality metrics. As a result, more life-sciences organizations are rethinking training, and starting to view it as a strategic part of quality assurance and control, and overall business goals.

	A growing number of pharmaceutical companies are now working to modernize training programs, to align training with compliance documentation and corporate strategy. This requires unifying processes across quality, content, and training systems for improved quality management. In a unified, end-to-end approach to training, users first identify and revise the documents that would be most significantly impacted by a deviation. Then, when a quality event does occur, the system automatically triggers and assigns training tasks to the right people. In this scenario, training is connected to document versions, change-control processes, and quality events, helping to support broad organizational goals to improve quality metrics.

	Getting to an end-to-end approach will take some time and effort, but following the five steps below will lay the groundwork for making training a strategic asset.

	Develop a bill of learning that attaches trainable behaviors to key quality metrics

	Bridging the gap between a business goal and training starts with a bill of learning, which breaks the goal down into discrete, measurable learning objectives for a specific skill set. Educational initiatives can then be tied to a company’s strategic direction, helping improve critical metrics. In addition, a bill of learning can help demonstrate the impact that training has on the overall business.

), a pharmaceutical company has encountered out-of-specifications (OOS) due to failed lab tests. The quality event is ruled to be not a lab issue, but a manufacturing deviation resulting from contaminated material introduced when equipment was not properly cleaned. This scenario has happened before, so in response, the company establishes a strategic goal to decrease deviations, specifically related to proper cleaning techniques.

	The objective to decrease deviations is divided into the actions needed to meet this goal, such as implementing the correct cleaning procedures related to the manufacturing process. To implement the right manufacturing process, quality teams want to identify process improvements and increase employees’ knowledge of performing a process properly. The company decides that to reinforce knowledge of how to execute a process-in this case, cleaning techniques-individuals’ ability to follow SOPs without deviation must by improved.

	This is where training comes in, to identify and correct quality professionals’ ability to follow the procedure. Ultimately, the bill of learning makes it easy to understand the impact of not following proper SOPs, which helps reinforce the importance of following approved processes without deviation.

	“With a bill of learning, companies can break a strategic objective into specific learning components and link the learning outcomes back to the organization,” says Karl Kapp, director of the Institute for Interactive Technologies and professor of instructional technology at Bloomsburg University. “In doing this, companies effectively connect quality and compliance, gathering metrics that can be measured against corporate objectives to continuously improve quality processes.”

	A modern solution unifies training and quality management, enabling teams to track quality metrics and link them back to training to ensure effectiveness. Nationally or globally dispersed organizations can bring together SOPs, quality processes, and training with complete transparency. In this example, companies identified documentation related to this specific deviation and built training around the recurring behavioral gaps. With a bill of learning, training is also attached to a corporate objective to ensure alignment across internal and external stakeholders.

	“At Tolmar, one of our quality goals is ‘do it right the first time,’ and a cloud-based training solution provides a strong foundation for this goal,” says Miller. “Many pharmaceutical companies have a program or process for SOP training, but most of these programs are inefficient. A training system in the cloud that’s connected to quality processes and content helps streamline our training, so we are more confident that critical documents have been read and understood.”

	Once a bill of learning has been established, the next step is to specify learner roles-the foundation for role-based training. Modern role-based training uses a combination of job responsibility, function, and hierarchical level within the department or organization.

	With legacy technologies, learner roles are often exclusively tied to a specific job title or ID, limiting the ability to deliver precise content to each person. People are often undertrained or placed in more than one group and over-trained. Both situations present compliance risks. Without the ability to deliver appropriate, contextual content, it is almost impossible to build a flexible and scalable training program while ensuring compliance.

	For example, without role-based training, every employee in a quality manufacturing department receives the same curriculum, such as training on 85 SOPs and work instructions. With flexible, role-based training, organizations deliver tailored content to specific roles such as a quality manager, quality assurance associate, or documentation specialist. Instead of being trained on all 85 SOPs and work instructions, a quality assurance associate would only train on the 25 that are specific to his or her role. Assigning a specific curriculum to each role helps to reinforce the learning objectives that directly connect to those responsibilities.

	Defining learner roles is a critical first step in implementing a role-based training curriculum, and it starts by asking questions like, “Is each role specific to one department, job, or function, or combination of these attributes?” or “Which roles are applicable to the behaviors identified in a bill of learning?” The answers will help teams tailor training programs to ensure that the right content reaches the right people, to do the right job, at the right time.

	Modern training solutions connect training to learner roles in an end-to-end process within the quality system. A quality document is tagged as required training, and, in the event of a deviation, the content is revised via change control. The revised document is then automatically reassigned to learners as a training task. For example, when the equipment cleaning process is modified, the SOP is flagged as required training. With role-based training, the SOP training task will automatically be sent only to the employees that use the equipment, instead of everyone on the manufacturing floor. In the end, this approach allows companies to deliver the right content to more precisely segmented audiences without over- or under-training, increasing efficiency and compliance.

	“The ability to track a user’s training status or assessment for any training document enables management to ensure only those qualified to perform a particular operation can do so,” says Miller. “For example, if someone is out for the day, it’s easy to find other qualified employees to perform a task, helping minimize compliance risk and improve daily operations.”

	Use microlearning to connect critical content to learner roles

	After determining learner roles, organizations can apply microlearning techniques to break down larger and more complex SOPs to develop hyper-focused content for their role-based training programs. For example, if many deviations have been linked with a failure-to-follow a key SOP, companies can then divide that SOP into smaller, targeted learning assets to help staff focus on the necessary skills. An organization could create a short, two-minute video to demonstrate only a specific cleaning procedure to support a longer SOP. Since each task is connected to a larger instructional objective, microlearning reinforces the right behaviors for better performance that improve strategic quality objectives.

	“Performance support and learning are inextricably linked,” says Kapp. “In any organization, we learn because we want a certain outcome. We want learners to perform an action correctly, so microlearning can really be an invaluable tool for supporting improved performance.”

	Microlearning in a unified quality system helps make the learning journey holistic, instead of introducing learning as a series of one-off events. Once a quality procedure has been revised, the system automatically re-assigns training for that SOP based on the pre-determined learner roles. This approach helps ensure that learners are not only reading and understanding documents, but also applying that knowledge to their daily tasks effectively.

	“We want to expand our program to go beyond simply training on SOPs and see if specific training has a real impact on an individual’s performance,” says Miller. “With our cloud-based application, we can use concrete evidence, such as results from on-the-job training, to assess an employee’s comprehension. Doing it right the first time will help us avoid rework and costly errors.”

	Microlearning can only be as effective as when, where, and how it is deployed. Companies can expect better results from training programs by shifting from individual, content-driven events to learning that is deeply contextual, social, and embedded into real work (2).

	Considering how much information is consumed via technology every day, meeting learners where they learn best-in the flow of their work and day-to-day life-is crucial. The average person checks his or her smartphone nine times an hour and pays attention to specific content for less than seven seconds (2). In fact, smartphones dominate as learning technology, and recent research has shown that 70% use their mobile devices to learn (3).

	Where and when learning takes place should also be considered when deploying training materials. A large percentage of learning happens during the workday, with 27% of learners consuming content during the work commute and 42% at work. Since more than half of individuals learn at the point of need, microlearning can greatly impact learning objectives by delivering learning events more rapidly and frequently.

	“When a learner needs to retrain on the appropriate steps to execute an action, they can access training in the flow of their work when they need it most, without delay or interruption,” says Kapp. “This is an example of how microlearning and the strategic goals of an organization can come together to create the right learning environment.”

	One solution for training enables both learners and trainers to focus on the right content, at the right time, across devices. More pharmaceutical companies are using tablets in manufacturing facilities so people can access the relevant work instructions they need at any station on the shop floor. Employees ensure they are performing the right action while they work and can reference training content at any time, on any station. For example, a video that demonstrates cleaning procedures can be available via a smartphone so learners can train on how to clean machinery as needed. By connecting learners with training content at the time of need and according to their learning habits, companies can better change behaviors to decrease quality events.

	Generate insight and take action to realize measurable impact

	Many organizations have encountered difficulties generating comprehensive reports around training or qualification tasks and how they are related to compliance. Training tasks live in a different place than the training content, such as in a document management system, email, or in multiple learning platforms, reducing visibility.

	End-to-end insight in a unified system enables companies to understand how training is related to quality objectives to make better, more informed decisions. Once a training initiative has been  completed, teams generate reports that include which critical content and version are associated with deviations, when corresponding training materials linked to a deviation were consumed, and whether the number of deviations decreased as a result.

	With quality processes, documentation, and training unified in one solution, quality teams can then effectively report on strategic metrics and the return on investment of the training program.  A bill of learning in a unified system provides a direct correlation from the discovery of an issue to the deployment of training and a tangible process improvement.

	“Direct integration between our training, documents, and processes allows us to measure the impact of training and determine if training is helping us meet strategic goals,” says Miller. “We can schedule training for new and revised documents, link quality events like corrective and preventive actions to training tasks, and measure the results. These new capabilities, only possible with a unified platform, will eliminate manual processes and allow us to stay dynamic and better align our processes with quality objectives.”

	Strategic training to improve quality metrics

	Corporate learning in life sciences has the potential, not only to improve productivity and reduce errors, but to also become an important source of strategic, competitive advantage (3). These five steps offer a starting place to drive continuous process improvement in quality. By continually breaking down a strategic objective into specific learning components, companies teach to those components and apply the outcomes to the organization. At the conclusion of the process, teams provide metrics that are directly associated with the strategic advantage, measuring improvement and building better quality programs around a specific learning objective.

	The cloud is enabling the industry to bring training and quality processes together and transform quality management. The results of doing so include saving time by accelerating internal audit preparation and onboarding team members faster, as well as improving compliance as more quality professionals can execute their jobs better. Correlating training results to quality objectives will enable organizations to make more informed decisions and rethink training as a critical business strategy.

	By connecting quality management and training in a single application and applying modern learning techniques, life-sciences companies can create an effective training program that’s measurable across the organization.

	1. B. Unger, “An Analysis of FDA FY2017 Drug GMP Warning Letters,” pharmaceuticalonline.com, January 10, 2018
	2. S. Penfold, “

Seven Mobile Learning Design Strategies: Tips, Examples, and Demos,

” elucidate.com, April 19, 2017. 
	3. J. Bersin, “

How Corporate Learning Drives Competitive Advantage


	Vol. 42, No. 12
	December 2018
	Pages: 26–29

	When referring to this article, please cite it as Kent Malmros, Make Training a Strategic Asset: Five Key Steps," Pharmaceutical Technology 42 (12) 2018.

Simplified role-based training can lead to better quality metrics and compliance.