Building Success into Employee Training Programs
May 26, 2020
In this 4-part blog series, Hélène Pora, Vice President of Technical Communications & Regulatory Strategy offers insight into one of the greatest challenges facing the biopharmaceutical industry today: employee training.
Part Four: Building Success into Employee Training Programs
In part one of our series we focused on Acknowledging the Biopharmaceutical Skills Gap and then addressed Industry Training Challenges in part two. Part three started to explore Novel Solutions to Closing the Skills Gap , and now we close with a look at the future of training.
Where Training Stands
Throughout the manufacturing industry, traditional training models have an expert who trains staff directly. Biopharmaceutical manufacturing training mirrors this approach with a focus on current Good Manufacturing Practice (cGMP) compliance. The traditional training approach has been a combination of live demonstration, written instruction and supervision centered on standard operating procedures (SOPs), working instructions (WIs) and batch records (BRs).
While these methods do work, there are barriers to their effectiveness, including:
- Language barriers and styles of communication, which can create a loss in translation.
- Differences in learning style and retention.
- Instructor(s)/expert(s) availability—if there are only a handful of experts, or the expert leaves or is frequently unavailable, it can be catastrophic.
- Learning limited to specific timeframes (i.e. only during pre-determined training sessions) results in limited success.
A New Set of Training Tools
A misconception exists that "the more detailed the training document, the better", but reading alone is not enough. Visual and oral instruction are needed, along with consistency.
Each person is individual and learns in their own way, so our goal at Pall Biotech became offering access to information in a format that customer employees can work with in their schedule – basically, training on demand. Our holistic training methodology features digital learning and training assets in the form of interactive images and animations, supplemented by videos and live content produced in conjunction with the expert and quality assurance teams.
Using Technology to Train
Pall Biotech has developed a series of digital training assets that help the user to visualize the technology and the activity being referenced. These learning modules provide a knowledge foundation for each technology and are made available via smart media tools, such as tablets and iPads♦, in line with operations.
The capability to document, demonstrate and explain complex manual steps unambiguously and consistently represents a quantum advance over existing training tools. Content in the media books can help visualize or demonstrate what is happening behind the “walls” by providing the principles applied and the rationale of process attributes. This is a key element in creating a learning pathway that gives operators a better understanding of the key process attributes.
Using these tools, our own teams and the customer can support:
1. GMP compliant process operations that reconcile tacit and explicit knowledge by previewing instructions that a wide range of stakeholders such a Quality Assurance, Regulatory and Process Sciences can access for proper and uniform technique.
2. Off-line training capabilities that reduce the expense and required time of training.
3. Multiple repetitions of a process in the digital format (prior to real-life application) reduces the risk to operations, products and ultimately to patients.
4. Rapid knowledge enhancement for non-frequent, but critical, activities prior to being performed (like system installation, bioreactor set-up, clarification activities, etc.).
5. Reduced risks of losing knowledge and expertise as skilled operators move to other roles because the information is always available.
6. Operations excellence in tech transfer, effectively eliminating deviations in production.
Using a secured private cloud ensures security of the information and that the instructions are available to be conveyed at the point of use where the approved user needs it. Keeping the practical know-how on a dedicated secured web cloud also provides an economy of scale since the gated access, permissions and rights assigned to the user profiles allow sharing of expert knowledge at will.
Additionally, on-demand deployment does not require any CAPEX and provides clear advantages, including:
- Full visibility and quality control of the learning assets.
- Data collection helps shape future training and applications.
- On demand training for real time learning.
- Publishing on multiple outputs with tracking/analytics.
- Opportunity to monitor competence and see where mentoring is needed.
Continuously Improving Bioprocesses
As a supplier, Pall Biotech understands that your success translates into our success and we focus on refining our offer to help you gain compliant efficiency. We do not expect the industry to throw out existing training methods, but by taking a blended approach to training with hands-on sessions complemented by on-demand, interactive digital learning, the biopharma skills gap can become a thing of the past.
View the Biotech regulatory support portal.
Hélène Pora – Vice President, Technical Communication and Regulatory Strategy
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