Innovating GXP training by understanding type and method of training.

Every pharmaceutical company might be investing a lot on training of their employees. Despite of this fact many companies suffer in FDA inspections getting 483s on either lack of training or inefficient training's.

One may think that even after giving lots of classroom training's and repeated SOP training's why employees  do errors or why is the training concluded as inefficient.Although this question can be answered in different ways but the science behind training needs to be understood well and the science lies in the human brain.

Human brain has different lobes and development of different lobes decide which type of learning is better for an individual

There are three types of learning based on these intelligence

1.      Audio learning:

2.      Visual learning

3.      Kinesthetic (Activity based) learning

Based on the above facts only SOP reading or classroom trainings may not develop well to each individual hence visuals like video trainings or displaying charts or images may make person grasp faster and permanent.

Kinesthetic training will involve more about carrying out demonstration of actual operations or activities which will make it easier to understand.  Training modules in pharma industry therefore need to be made based on all 3 types of learnings rather than only classroom trainings.

Now let’s discuss which types of trainings are most common in life science industry and understand reason behind inefficient training in life science companies. Increasing training awareness allowed us to understand the difference between various modes of training and identify the most effective training method. Yet industries unable to comply with FDA expectation of training compliance on shop floor and receive observations during routine inspections.

There are three basic mode of training conducted in life science companies

Read and understood: This type of training allow trainee to go through the document required to be trained i.e. SOP, WI,JA, Policy. In current learning management system (LMS) world approved documents are sitting in validated document management system (EDMS) for user to read and understand the most recent version of the document. Further at the end of the training user acknowledge that he/she has completely gone through the document and understood the purpose of document.

Instructor led : This type of training require classroom, students,  instructor, attendance sheet , training evaluation in form of verbal or written questioner.  Instructor led session involve two way communication where instructor deliver the content of the topic with the help of flyers, power point presentation, posters, hard copy of printed SOPs. Instructor allows trainees to ask questions to help them understand the topic of training up to the point of execution excellence. At the end of the session instructor use either verbal mode of evaluation where he/she ask question to audience and assess their level of understanding. Sometime instructor distribute questioner and ask trainees to mark their answers and provide answers at the end of the sessions.

Web base training: Web base training has replaced the traditional video presentation due to increasing number of LMS implementation in life science companies. LMS allow e-learnings to work efficiently with the help of visuals, diagrams, flow charts, symbols, icons, PowerPoint presentations. Web base training may range from 10 to 50 min depend upon the type of training and number of test assessment. Web base training provides content with audio and video method followed by series of questions with a test minimum mark pass criteria. System evaluates the right against the wrong answers and provides the results to trainee on the same screen. Many training manager require their trainees to go over the training content again and again until they clear the test at the end of the training.

There is another type of training method that meets the requirements of kinesthetic training known as “ON Job Training”. Where carrying out demonstration of actual operations or activities are part of training to ensure ease in conceptual understanding.  However considering the number of employees in any company and number of qualified trainers for On Job Training, it seems impossible to implement this type of training across the board for everyone.

Conclusion :

Therefore I was thinking how utilizing e-learning platforms and concept of kinesthetic training to increase the learning efficiency of trainees. Similar to or X-Box or Play station games where we have scenarios to complete in order to play the next level of the game, we can create scenario of manufacturing processes such as Sterilization, batch process. User need to interact with the system in order to complete the training module for example in training module on process flow user need to click on the right valves to ensure flow of process solutions in right reactors to complete the process. If he open the right values, implement the right pressure and select the right vessel ensure his successful completion of training module.

Such type of training sessions can be very effective in making trainee understand the true purpose of the training. Also trainee will feel such training methods interactive, interesting, grasping the critical process steps and remembers the critical steps and purpose of the training.