The GMP eLearning Business Case
Technology now seamlessly permeates our daily lives. Social networking has changed the way we communicate, and smart phones have placed the world’s information at our fingertips. Improvements in graphical user interface technology now makes it easy for a five-, or eighty-five, year-old to easily swipe through digital content.
So it would seem that online GMP training makes good business sense, but it is still not used extensively in the pharmaceutical or medical device industries.
Why do we want to hang on to old school training? Perhaps the main reason for slow adoption of online training is trust. Has industry been fearful of the costs involved with computer systems validation? Has regulatory burden made pharmaceutical manufacturers nervous of online GMP training?
New starter and annual refresher training is a GMP requirement. We could use a specific example of an operator working in a tableting plant, who needs new starter training and annual refresher training but let’s look at the big picture instead. There’s a quote floating around on the internet that goes something like this:
A CEO and Finance Director (FD) were talking:
The FD asked the CEO, “What if we spend all this time and money on our staff and they leave?”
The CEO responded, “What if we don’t and they stay?”
In our competitive labour market attracting and retaining talent is incredibly hard. We all want to have highly skilled, well trained and motivated staff. Over the years it has become evident that not only are highly trained staff properly equipped to perform their role, but they are energised after receiving good training, are less likely to leave, and enjoy higher levels of professional confidence and personal job satisfaction.
Training pays and eLearning can be a cost-effective tool to motivate and energise your staff. The compliance tick is a consequential benefit.
Whilst there are GMP issues common to all plants, like accuracy of records, good hygiene, deviations, change control, etc., we have to acknowledge the significant difference between sterile and non-sterile manufacturing. Therefore this discussion will concentrate on common GMP issues within the thousands of non-sterile Oral Solid Dosage (OSD) plants in the world, expanding on the specific value adding scenarios based on eLearning vs classroom training. But first we’ll set the scene.
The 3 Biggest Training Barriers
As experienced consultants, working at the coalface of life science industries, we’ve observed many issues associated with disparities in understanding when it comes to working in these GMP regulated environments. Human error poses the biggest risk in terms of safety and compliance, yet still training is overlooked as the most effective way to minimise human error and improve regulatory understanding.
Why is training overlooked? Usually because of three main concerns:
PharmOut is in the business of offering solutions for companies seeking to gain a competitive advantage. We realise the practicalities of instructor-led training isn’t always the most convenient or viable option. For this reason we offer eLearning as a cost-effective alternative method of training that addresses the three main concerns associated with training provision. Let us elaborate…
According to the latest latest ABS survey of labour mobility in excess of 50% of Australian workers have been in their current job for less than five years. Approximately one quarter of Australian workers experienced a change of job in the last 12 months. Research indicates people change jobs on average every three years. An average of 2.6% of the Australian workforce is absent due to illness on any given work day.
Now consider this; if you have 100 employees it would be reasonable to assume that 30 of those will experience a change in employment circumstances within the next year and at least 2 or 3 will be absent from work right now.
When it comes to managing a training programme, statistics like these paint a favourable picture of eLearning.
You schedule yearly classroom based training for 100 employees to meet GMP compliance requirements for annual refresher training. On the day of the training 5 people could not attend, two were on sick leave. Within three weeks after the training was delivered 1 employee left and 2 new employees started. You have 7 people that still require training. With eLearning, training is always available, anytime, anywhere.
GMP Part I – 2.9 “Beside the basic training on the theory and practice of Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed.“
Money is perhaps the number one concern. Many people only examine the cost saving aspect and ignore the return on investment (ROI) aspect of eLearning, such as staff operational performance. According to a Merrill Lynch study, Motorola estimated that every $1 spent on training delivered $30 in productivity gains within three years.
In terms of cost saving though, eLearning stacks up well. In some cases it is estimated that up to 40% of every dollar spent on traditional training is spent on travel costs (Merrill Lynch, the Book of Knowledge, 1999).
A company needs to put 50 employees through a GMP refresher course. The average hourly wage is $40 an hour per person.
Classroom: The cost of class room training for half a day (4 hours) is $2500. The wage cost alone for half a day is $8000 (50 x $40 x 4). The cost of training (excluding travel and equipment costs) could therefore be estimated at $10,500. Now let’s put a productivity cost on top of that. Let’s assume the average hourly wage, inclusive of productivity, is $100 an hour per person. The wage cost now becomes $20,000 (50 x $100 x 4). A conservative estimate for classroom training now hovers around $22,500.
eLearning: By way of comparison, an online course costs $75 per seat (per person). The cost for 50 employees would be $3750. Now factor in the volume discount for bulk purchases and the cost is reduced to $1875 (less 50%). The duration for this module is on average 1.5 hours. The wage cost for eLearning is around $3000 (50 x $40 x 1.5). The cost of eLearning is now around $4875. Training can be scheduled during downtime, maintenance periods, when production demands are low. Now what if employees did the training in their own time, after hours? The total cost for eLearning would be $1875.
Our own course costing demonstrates that eLearning can yield considerable cost savings over traditional classroom based training. The scenario above supports the findings of many reputable studies into the cost savings associated with eLearning.
Training and education often end up at the bottom of organisational priorities. It should be at the top. Without a training program, people learn from trial and error, what they observe around them, and what they draw from prior experience. “Practice does not make perfect. Only perfect practice makes perfect.” (Vince Lombardi).
PharmOut training content is created by subject matter experts (SMEs) and professional instructional designers, with years of industry experience and extensive knowledge of GMP regulations. They respectively have hands-on experience in meeting audit and inspection requirements, and a background knowledge in adult learning theories with a demonstrated aptitude for teaching and training. An independent white paper compiled by a recruitment firm (Hays) in 2011 found that organisations with good internal and external training systems in place not only had better skilled staff but they retained staff and reduced turnover.
A packaging operator is doing their job, the maintenance technician informs them that they need to shut down the line for an hour for urgent unscheduled maintenance, the packaging operator is still on the clock and is directed by the head of production to use this time to complete some online training (eLearning). In roughly the equivalent duration of a lunch break, the packaging operator has completed a module on Good Manufacturing Practice, and has obtained a certificate of completion as evidence of the record of training. The factory worker has not only fulfilled the compliance requirements for ongoing training, but whilst studying the module was able to relate the information on GxP to their current role. With this information fresh in their mind, upon returning to work, the worker noticed a loose cover and on examination discovered an accumulation of debris, immediately reporting this to the maintenance technician who was able to rectify the situation minimising further downtime.
GMP Part I – 2.9 “Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.”
GMP Part II – 3.12 “Training should be regularly conducted by qualified individuals and should cover, at a minimum, the particular operations that the employee performs and GMP as it relates to the employee’s functions. Records of training should be maintained. Training should be periodically assessed.”
Key Points – the eLearning Value Proposition:
- Down time is minimised, keeping things running
- ELearning can serve as induction training for new employees starting
- Workforce knowledge can be brought to a common basic level
- With 12 months access, eLearning content can serve as an ongoing reference tool
- Breakdowns etc. can be viewed as an opportunity to do on demand training
- Employees do not need to be sent off site, eLearning is location independent, training can take place anywhere
- Content is standardised and consistent, the same training and consistent messages are delivered to all
- Productivity isn’t compromised, eLearning utilises small time increments
- The focus is on training that is needed, with unlimited reach to learners
- ELearning is more than just text, it is fully narrated, interactive and engaging
- There are numerous cost savings in comparison to traditional forms of training; travel, accommodation, trainer time, facility and equipment cost, paper and materials, time away from production
- Certificates are generated with unique validation numbers for audit purposes, these can be stored electronically, and training is time stamped
- ELearning meets the needs of diverse learners, and is associated with less stress as study can be completed at the users own pace with no pressure from others
- Trainees are able to spend more time on concepts that aren’t familiar and can skim through those that they are more acquainted with
In many instances eLearning wins hands down over classroom training when it comes to cost, in both time and monetary value! Technology is woven into the fabric of daily living, often completely invisible, we trust it without question on a daily basis. In relation to eLearning what if, for a moment, we forget the technology and just consider the training component in isolation. When viewed in this way it becomes an uncomplicated service that can be delivered immediately. ELearning isn’t about technology, it’s about learning and development using technology.