Breaking paradigms in the life sciences industry

Conventional training methods have not proven to be as effective as expected in improving performance in pharmaceutical operations. A solution, combining the Socratic method of teaching and new technology has been shown to be effective for obtaining the desired results from training. Better yet, education is provided and the level of knowledge of the workforce increases. The more information is provided to the workforce, the greater the awareness within the organization. Subsequently, this lowers the amount of deviations and errors, and consequently increases the quality and reduces the cost of compliance. An alternative is discussed, which has proven to be effective in communicating know-how, accessibility, and improving the skills of the workforce within a paperless environment.

Updating your workforce capacities through periodical training is always a great investment for your company since it assures productivity, compliance and fast corporate growth. In the pharmaceutical industry, for example, continuous training is a must due to the manufacturing processes complexity, as well as regulatory requirements. Regulatory issues and technology keep evolving all the time. An innovation might become obsolete in a year or two, and technicians need to keep their skills up to date all the time. If you are either launching a new product or a new technological approach, you need a well trained staff in order to face all challenges that come along.

A successful business depends upon its workforce proficiency (defined as mastery, skilfulness, or the ability to apply knowledge). All of these are gained through practice. However, because of the cost of pharmaceutical operations, as well as the technical and regulatory complexity of manufacturing processes in this industry, practice is gained through time. This makes the road to a proficient workforce an uphill endeavour.

Employees gaining proficiency in operations and regulatory knowledge become an asset but at the same time a resource that cannot be lost. Nevertheless, losing a proficient employee happens on a daily basis in the business world, which represents lost productivity. Most companies invest millions of dollars training their workforce only to lose a good portion of them through attrition or retirement. Thus, the investment is lost and has to be made again with new recruits.

Workforce training assures more productivity, improves communication among employees, and makes the decision making process more assertive since your staff will feel more secure about their skills. But, productivity is often hindered when experienced resources are promoted or leave the company. In addition, the cost of replacing the resource, often overlooked when budgeting, is paid when an expensive resource has to be recruited in order to replace the experienced worker who left.

Conventional versus Proposed Methods

Most training methods focus on lecturing and reading, followed by a test discussed among employees. Skills are learned while on the job, sometimes with a minimum supervision relying on ill defined proficiency test. Others place subject matter experts along with an unskilled staff in order to train them while on the job.

Other alternatives such as electronic or web-based trainings often fail to provide the necessary approach to teaching, mentoring or keeping the resource motivated during the learning process. Most of the time they fail in achieving desired learning goals and only provide a compliance tool for training.

The previous are all valid approaches but are not the solution to the development of a proficient workforce. Electronic training is only a delivery method, but it doesn’t substitute a teacher. An effective learning process requires the student to be empowered through a challenging topic development, virtual laboratories, and case studies.

It is the delivery, surrounding, and readiness of the student that provide the right learning environment. On the other hand, not all trainers are necessarily good teachers (someone who knows how to deliver knowledge and how to keep students motivated through the learning process).

With this in mind, a new learning system was created, based in part in the Socratic method of teaching. It has proven to be an effective training tool for the pharmaceutical and life sciences industry in general. This interactive system makes learning not training the actual goal of a session. It is a learning approach with an interactive platform and is based on those factors which are crucial to achieving all learning goals in a particular training. Among some of these are: topic, resource’s background, age, role within the organization, delivery methodology, and time.

The system provides a multimedia experience that challenges the resource through his or her senses. As mentioned above it is delivered over the Socratic Method, allowing the student to gather information and absorb the experience through a virtual laboratory. A trainer or teacher is always available on-line to provide tutorial advice or to answer any questions about a particular topic, case or exercise.

It includes an interactive learning module that contains text, audio, video, animation, and a databased tracking system which allows you to view your employees’ knowledge acquisition. Its content and assessments are developed by subject matter experts, experienced researchers and instructors specialized in the pharmaceutical industry. By using rich multimedia technology the interactive learning system guarantees an enhanced learning experience by allowing users to interact with information.

It is interesting that this approach is being studied throughout some universities in the United States as a means to increase knowledge and interest in engineering and science careers. Such a program is the Research Experiences to Enhance Learning (REEL) being carried throughout the state of Ohio and funded by the National Science Foundation. The idea behind this approach is that the thrill of the discovery process associated with doing research will promote the students interest in the topic studied and help develop critical and independent thinking. Within the industry this would translate into taking the experience to the worker without leaving the site, while increasing their level of interest and knowledge.

This learning system is cost effective, upgradeable, measures users knowledge acquisition, has an easy to use interface, features rich multimedia capabilities (text, audio, video, experiments and games), allowing the organization to learn globally, users can learn at their own pace, it can be adjusted to work schedules or shifts, content is reusable and available to all employees, reduces manpower to deliver, supports multiple languages, can be customized to your specific need, and complies with 21 CFR Part 11, among other benefits.

Standard Operating Procedures (SOP)

Standard operating procedures define policies, processes and standards of operation and behaviour. However, conveying the idea or information is often a barrier to communication since converting abstract thought into written expression is never easy. Companies rely on SOP’s in order to accomplish daily tasks. Over the years, SOP’s have evolved into graphical documents which contain photos and graphical elements to explain procedures. Graphical SOP’s have helped companies improve their productivity but cannot guarantee that users understand 100% of the content. They are still cumbersome and complicated and do not solve the interpretation problem, the ease of learning or convey clearly how things are to be accomplished. Just monitor the amount of deviations or events caused by not following procedures.

However, an interactive document can be made a component of the interactive learning system. It becomes an On the Job Training (OJT) SOP solution that incorporates multimedia capabilities (audio explanation, video and/or animation) into documents. By combining these features, users can have a full understanding of how to perform specific tasks. It can be used in any manufacturing or office area as part of a paperless solution. However, one of the biggest applications is in aseptic areas where combined with a touch screen monitor or on a computer, allows the employee to have a reference information available at all times. It truly solves the age-old issue of creating a paperless environment.

The capabilities of the training method used in this system are incorporated into the SOP’s through the use of electronic documents. Therefore, understanding procedures become a simple guided process. It combines the written version of the SOP blended with the explanation as if a subject matter expert is beside each individual a every time. A visual is then added to the process converting it into an actual mentor, clearing any doubts and transferring knowledge efficiently and effectively. The electronic and interactive document complies with 21 CFR Part 11, contains bookmarks features, and provides audio, video and 3D animations and thumbnail views. It can be customized; it certainly avoids misinterpretation by the reader, and can be used in manufacturing and operating areas, with special use within aseptic environments.

Transferring knowledge and skills using a combination of electronic media and content development has proven to be an effective tool. It is a great solution to training problems, cost containment, and compliance issues within the industry. It is certainly the solution to training a broad base of employees and improving compliance with regulatory requirements.