Despite rapidly growing proclivity towards digitization and advanced technology applications, Pharma and Biotech industry continues to remain highly dependent on human competences. Review of the regulatory citations of recent past suggests, a major chunk of non-compliances are still due to knowledge or skill gaps - which can be directly or indirectly attributed to training effectiveness, even though they are not so explicitly mentioned in the observations. Obviously, the human performance variability and its impact on product quality has clearly grabbed the attention of the regulators worldwide. This is also evident from the newly published EU annex-1, that has such an elaborate section on ‘Personnel’ as compared to its last update in 2003.
This is apparently leading to increasing focus of the pharma organizations to make training as an important pillar of their quality systems. However, many top leaders of such organizations still wonder - why do so many people in the company fail to perform in the right way, even after going through the training programs 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 trainings 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 the new ways as they are afraid it might increase their workload or cause any inconvenience.
Current facility and process design doesn’t support implementation of new learnings.
New learnings are lost very fast due to unavailability of opportunity to practice on the ground. In such cases its unable to overcome the existing habits.
There is no mechanism to accurately evaluate the trainees’ competency before deployment on a job.
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