Trainings in pharma: Challenges and Solutions

If we look at the trend of recent regulatory citations, to me, most of them could be directly or indirectly attributed to personnel capability or practice-related issues. Obviously, human performance variability and its impact on product quality have clearly grabbed the attention of regulators worldwide. This is also evident from the newly published EU annexe-1, which has such an elaborate section on ‘Personnel’ as compared to its last update in 2003, with an increased reiteration of the word ‘training’ from 5 to 10 times in the current revision.

This is apparently leading to increasing focus of the pharma organisations to make training an important pillar of their quality systems. However, many top leaders of such organisations still wonder – why do so many people in the company fail to perform in the right way, even after going through the training programmes each year?

This is an obvious question, but the answer lies deep inside our current training systems in the pharma industry. A lot of previous research on this subject points towards the following reasons for training not being effective:

• Trainees do not receive the intended message fully because of barriers like language, attention or prior knowledge on the subject.
• They are not able to understand the criticality or usefulness of the subject they are trained on.
• They do not believe that the new methodology will work for them or it is any better than the current practice.
• They are also hesitant to try new ways as they are afraid it might increase their workload or cause any inconvenience.
• The current facility and process design doesn’t support the implementation of new learnings.
• New learnings are lost very fast due to the unavailability of opportunities to practice on the ground. In such cases, it’s unable to overcome the existing habits.
• There is no mechanism to accurately evaluate the trainees’ competency before deployment on a job.

The experiment by the German psychologist, Hermann Ebbinghaus, well known as the “Ebbinghaus forgetting curve”, demonstrates the information received is forgotten over time very fast when no systematic efforts are made to retain it (Figure 1).

A similar research by the National Training Laboratories (NTL) Institute finds that the effectiveness of training can be highest when you teach someone else or use the training immediately or practice what you learnt. On the contrary, it is least effective if it is classroom training or if you learn by self-reading (Figure 2).

The challenge today in the pharma industry is that we over-rely on classroom training and SOP readings with limited scope for on-the-job training for critical processes. In most cases, trainees do not get the opportunity to use their learnings immediately or practice their newly acquired skills/knowledge before they are actually qualified for a job role. Further, most of the post-training assessments are theoretical. This is due to obvious reasons of contamination of critical areas or the possibility of a loss of costly products and machine downtimes.

So how do you expect your training to be effective and for trainees to retain what they are taught for a long time?

This is like the ‘chicken-and-egg story’. On one hand, you cannot expect the trainees to gain reliable skills/knowledge without practising what they learnt or applying their new learnings on the ground – on the other, you cannot allow them to practice/perform on the actual shop floor before they are fully trained and certified. Then, what is the solution?

There could be only two options to solve this puzzle:

• Creating a training facility where all the required infrastructure is presently similar to an actual commercial facility with provision for test materials and experienced trainers. Although this could be an ideal scenario for training associates on people-dependent critical operations like in aseptic manufacturing or sterility testing, it needs a huge investment to maintain a parallel facility with utilities and material supplies, hence not always a good option.

• The second option is Virtual Reality (VR)-based training environments. Virtual Reality offers a huge opportunity to simulate an actual shop-floor environment near to real and provide an auto-guided immersive training platform that solves all the problems discussed above. VR as a training mode offers several advantages over conventional training in pharma. Some of them are listed below:

1. 1. Practice options: Once the right way to perform a task is explained, VR offers the opportunity to practice in a risk-and pressure-free environment, without any equipment downtime, environmental contamination or material wastage. 

   2. Instant correction: It provides instant feedback for all errors along with directions for correction. Participants get multiple opportunities to correct a practice till they are perfect on the task.

   3. Auto-guided training: VR-based training does not need a human trainer to communicate the message or evaluate the performance post-training. The entire program is auto-guided with a final evaluation of training results. This allows participants to take this training at their own convenience without waiting for any trainer.

   4. Better understanding: Visualisation of mistakes or error situations and their impact on the product and patients offer a deeper understanding of the ‘why’ behind each process and practice. This increases employee buy-in on the new subject.

   5. Better knowledge retention: Since VR training work on audio-visuals, demonstrations and practising options, it boosts knowledge retention several times higher than conventional training modes.

   6. Better employee engagement: With participants enjoying the whole experience and able to get aligned to the communicated message, the overall performance improves, which results in better employee engagement.

   7. Better efficiency: The end result is increased efficiency of training, reduction of overall training expenditure, reduction of human errors and related regulatory citations.

It’s the need of the day to change the current training systems in the pharma industry to move beyond a check box exercise to a real value-adding tool. The regulatory push that we are seeing in recent days is a clear indication towards that. However, we won’t be able to bridge this gap due to the inherent limitations in this industry, unless we adopt new technologies like virtual reality. VR has already a time-tested history in many industries, but still remains a huge untapped opportunity for pharma. Once leveraged to its full potential, it can be a game changer.

References

1. Easygenerator blog – “How to beat the forgetting curve” by Kasper Spiro

2. NNE article on Digitalization – “Virtual reality boosts daily operations in pharma manufacturing”

3. Pharmaceutical Online article – “Reviewing FY2017 FDA 483s: Training Failures Or A Learning Paradigm?”By Troy Fugate

4. EU GMP Annex-1 – “Manufacture of Sterile Medicinal Products”