As with many pharmaceutical companies, Quality Control’s training centered around reading numerous, complex Standard Operating Procedures (SOPs) and participating in lengthy on-the-job training (OJT). In addition, analysts were trained on all knowledge and skills required to perform a test, even if they had learned these skills when trained on earlier tests. As a result, time to qualify to independently perform a single QC test exceeded five weeks.
The Company must deliver safe and effective products to patients around the world. This is both a Company core value and a regulatory requirement. Consistently achieving this level of compliance requires that these products be produced by employees using aseptic processes in an aseptic environment. “Aseptic” means that the processes and work areas are free from contamination of harmful microorganisms. There are four levels of work area classifications for aseptic processing: from Class A, which has the most stringent aseptic requirements, through Class D, which has fewer, but specific requirements. Every action of every employee in classified work areas is critical to maintaining aseptic conditions.
Each Company site had its own in-depth “best practices,” aligned with regulatory requirements, for how employees must act in the various classified areas. In addition to each site having its own compliance best practices, sites also had their own training requirements supporting the best practices.
Additionally, training and practice on the aseptic skills needed to be scheduled when the work areas were not operational. Unqualified employees are not allowed in certain areas when actual product is being processed. This meant that aseptic best practice training was spread out over more time than otherwise necessary.
The Company built a global Aseptic Best Practice Training Program that would be based on a single set of aseptic best practices across the company and that would allow for more practice. The target audience for the initiative was employees who work in Class A and B areas, with the training focused on skill building.
The initiative began with a research phase. During this phase, an ILG analyst conducted interviews with: Sterility Assurance Center of Excellence stakeholders; operators and mechanics working in the targeted classifications; managers of these employees; and on-the-job trainers.
The goals of these interviews were to:
- Identify the global set of aseptic best practices that were critical to include in the program.
- Identify what “good” looked like for each of these best practices (that is, identify the standards for performance).
- Define the reasons for each best practice in terms of aseptic processing.
ILG then organized the collected best practices into logical groupings, which became the nine Aseptic Best Practice Training Program modules.
Given the importance of training and practice when needed and without taking down the production line, virtual reality (VR) was identified as an appropriate delivery method for eight of the modules.
(The best practices in the ninth module were better addressed using a solution blending video and interactive e-learning.) To ensure the VR modules could be effectively implemented within Company’s technical infrastructure, the team conducted a technology assessment. As a result, the use of VR was finalized, the Oculus Quest 2 was selected as the VR headset for the training, and a means for tracking completion of the modules was identified.
The next phase of the project was for ILG’s analyst to create detailed designs for all nine modules. The design document for each module presented the content outline and instructional strategies for each learning objective. The content outline included the scenario setting, the task, the best practices, and the “whys” for each practice. The instructional strategies explained what would happen in VR.
The VR team then began to develop the VR modules — one at a time. Development began with the creation of storyboards, based on the design document. These storyboards outlined the actual actions the learner would perform in the VR. The ILG analyst wrote the instructional content (the audio and text instructions, the feedback, and the “whys”). Once the storyboards for a module were completed, detailed 3D graphics development and VR programming were performed by ILG’s VR team.
The resulting VR experiences provided the Company with a unique way to train learners in aseptic best practices. The virtual space is realistic to the Company, and the scenarios in the modules are realistic situations that employees in Class A and B areas face regularly. The VR allows them to learn, practice, and demonstrate these tasks, without actually being in that physical space — and without needing a live trainer until final on-the-job qualification. The Aseptic Best Practices training, because it was designed to fit the needs and the use, is succeeding.
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