Quality's Unsung Hero: The GxP Training Matrix

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.

Prioritizing a GxP training matrix

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.

According to Code of Federal Regulations (CFR) 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.

Designing a strategic training matrix

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
• audit trails
• FDA Title 21 CFR Part 11 compliant electronic signatures
• 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."

Improving long-term inspection readiness

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).

References

1. FDA, Inspections, FDA, Accessed October 17, 2023.
2. Veeva Systems. Best Practices for Developing and Maintaining a GxP Training Matrix. Webinar. Veeva Systems, 2022.
3. FDA. Code of Federal Regulations Title 21, FDA, June 7, 2023.

About the author

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).