Paradigm Shift in Training Methodologies to Ensure GMP Understanding

October 12, 2023
by SeerPharma

Training is a core fundamental to a compliant Pharmaceutical Quality System. This aids in ensuring that manufactured products meet the required product standard that relate to safety, quality, and efficacy. Although training has been a main staple in the pharmaceutical industry for decades, the practice itself has had its challenges from internal resistance within the company to having to evolve with a dynamic industry.

Historically, training has been performed by having an operator read an SOP for a key task and then practically learn the task with the aid of a “trainer”. The operator would be assessed on the ability to execute the key task as per the SOP, and there may even be a theoretical quiz thrown into the training program for good measure. Typically, trainers are experienced staff through tenure and/or staff who have demonstrated a high level of competency for performing that key task with minimal errors. However, such criteria for selecting trainers may be flawed, and thus lead to a suboptimal training experience which could potentially translate into poor execution of key tasks over time, and allow for greater skill degradation.

PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE-009-17 Part I Clause 2.7 (vi) and 2.8 (vii) has put a specific emphasis on the training of personnel. Although this is nothing new (with the requirement being present in previous versions of the guideline), what needs to be addressed is the paradigm shift of how training is executed and where so many companies are going wrong.

Gone are the days when you could simply get an operator to read an SOP and pair them up with “buddy” and they would be on their way.

Modern advancements in technologies have led to significant automation. Large Language Models (LLMs) and Machine Learning (ML) are being used to reduce the number of manual tasks and significantly increase the “technical know-how” required to interact with these complex systems. Furthermore, these technological advancements could potentially reduce the perceived need for critical thinking skills, such as the overuse of AI to solve problems. This is where the paradigm shift is evident. Nowadays, facilitators are required to impart a level of knowledge that is far more reaching than just completing a simple manual task, and the trainee needs to develop a skill set in how to ask the right questions and understand how to quickly make considerations for contributing factors to an issue that needs to be solved through the interaction with such technologies. That is the use of ‘Critical Thinking’.

This is coupled with the need for companies to adapt to new training methodologies and ways to impart knowledge to develop these skills and make training more efficient, effective and ensure a comprehensive understanding of the GMPs. Such new training methodologies could include augmented reality (AR), virtual reality (VR) and interactions with large language models (LLMs).

Effective Training Concept

So the question is, how do you select people who are effective learning facilitators, who can use such technologies in a manner that enriches the learning experience and fosters an environment of learning, the development of critical thinking skills and the comprehension of GMPs, in a world where everything is being developed to potentially reduce such skills and understanding?

The answer lies in identifying people with the right attributes and not necessarily with the perceived “correct” skillset. The issue is that the attributes required are often inherently linked to one’s personality. Therefore, it may be prudent to search outside the company to find the right person to perform training. This may mean moving away from the conventional use of staff who have been long-standing within the company. Attributes of a ‘Critical Thinker’ include:

  • Patience
  • Calm demeanour
  • Adaptive
  • Reflective
  • Unbiased
  • Exceptional communicator
  • Personable

Moving forward, it is now more important than ever, for companies to hire people with the above ‘Critical Thinking’ attributes to ensure trainers are effective facilitators who can interact with complex systems and use modern technologies to enrich the training experience. This will lead to better-performing operators, increased efficiencies, reduced quality issues/production downtime and a better comprehension of GMPs thus ensuring compliance and patient safety are maintained.

The team at SeerPharma that delivers regular and ongoing training to organisations is recruited with these specific skills and experience in mind. We are actively working in the background in adopting and deploying new tools and methods to enhance the training experience and help with the transfer of knowledge.

Contact us should you wish to learn more about how SeerPharma can assist in developing and delivering GMP training courses to your organisation.

Filed Under: gmp training