Why eLearning should be part of your regulatory compliance training programs — including during a pandemic.

The GMP eLearning Business Case

When we consider why eLearning is a valuable addition to GMP training programs, the following concepts come to mind: accessibility, scheduling adaptability, affordability (training cost savings), and regulatory compliance reinforcement.

There is no doubt that technology now permeates our daily lives.

Technology has also forever changed the face of education — or rather, the “face-to-face” of education.

eLearning and ‘virtual classroom’ training modalities have solidly replaced ‘face-to-face’ education in an era that means gathering in a room and exchanging minute particles could result in the inadvertent sharing of a deadly virus.

And with today’s technologies — that’s a risk we no longer have to take.

Preferred training modalities

Online courses and ‘face-to-face on-screen’

Online courses (eLearning) and virtual training delivery methods have emerged as the preferred training options for Universities and business sectors, especially in relation to the pandemic.

But the fact is that eLearning and web-based training delivery modalities have always worked well for:

organisations who can’t afford a shut-down and/or who can’t train team members all at once (due to scheduling conflicts)
organisations who need to limit preventable exposures to viruses, environmental pollutants, contaminants, etc.
companies with large and/or remotely located workforces
employees and employers with families and/or caretaking obligations
education providers competing for students at an international, national, and/or state level

eLearning also works particularly well when we’re in the midst of a pandemic that interrupts travel, limits our safety when we gather in numbers, and otherwise places us — and our businesses — at risk.

Pharmaceutical Manufacturing and GMP Training Industries

Interestingly, pharmaceutical manufacturing training programs and medical device industries have not fully embraced the benefits of eLearning — and Zoom-based courses — despite most other industries have currently done so.

It seems that a number of pharmaceutical industry manufacturers remain reluctant to change from ‘face-to-face in-person training sessions’ to ‘face to face via Zoom’ or 24/7 eLearning options for Certificate GMP training courses.

Let’s explore why that is — and why this is the perfect time for training delivery-modality changes in the Pharmaceutical and Medical device manufacturing industries.

When considering adaptation to new, improved technologies, there will always be people who are ‘early adopters’ — and those that lag behind. The same can also be said for industries. Certain industries recognise the benefits of making changes sooner than others, and other sectors lag behind.

The fact remains, however, that technological changes in today’s markets are occurring constantly. They are being designed, and implemented, at increasingly faster rates.

And as we’ve seen with the following technological advances:

ALL industries will need to adapt to advancing technologies, at some point in the future.
It’s not a matter of IF — but when.

The ‘WHEN’ of change adoption is not only associated with timing implications – it comes at a cost.

Late adoption vs early adoption always involves a cost.
And in terms of what the COVID-19 pandemic means to personnel safety AND to business sustainability — early adoption of protective measures is crucial for survival – quite literally, for people, and increasingly, for businesses as well.

The cost of not conducting GMP training during a pandemic, or using online delivery methods where feasible, might result in detrimental gaps in compliance training programs, AUDIT findings, deviations, product recalls — or worse.

Using digital technologies to maintain a compliance culture just makes sense. It’s been shown to be a profitable investment in terms of ROI, as detailed below.

Our lives are now intricately linked to technological advances.

When we think about “WHY” we need to adapt (that is, the WHEN, not IF) — let’s reminisce about how organisations grew to accept the following innovations. A majority of today’s business essentials, listed below, weren’t even a concept a mere two or three decades ago.

The top 10 digital technology advances that have significantly altered most aspects of our lives, long before the pandemic, include:

Email: near-instant communication capacity from anywhere there’s a reliable internet connection
Digital file transfers: rapid exchanges of information (documents, photographs, videos, digital contracts, etc.)
Mobile phone technologies: information at our fingertips (24 hours a day, 7 days a week)
GUI technology: improvements in graphical user interface (GUI) technologies (and device sizes) that allow a three-year-old — or an eighty-three-year-old — to easily swipe through digital content
Portable communication devices: smaller, lighter ‘smart devices’ used to access information and/or to connect with colleagues, family, friends
Social media/social networking platforms: changing the manner, type, frequency, and amplification (sharing) of information/communication
Professional networking sites: including LinkedIn broadening our reach within, and external to, our industry and field of expertise
Wearables: Software as a Medical Device (SaMD) or as a fitness tracking device
3D printing/architecture/software programs: sophisticated software that now enables 3D printing, precision architectural and engineering designs, ‘virtual experiences’ (pre-construction facility tours/virtual manufacturing facility walk-throughs, and remote auditing
Video platforms: webinar and video conferencing services, such as Zoom, improved the way we connect with others, including providing safe “virtual” face-to-face GMP course delivery during a pandemic.

Digital education and GMP courses

In terms of Digital Education, the benefits of eLearning include rapid access to information, 24/7 education availability, and significant reductions in training costs.

So it would seem that online GMP training makes good business sense (read the business case for eLearning in Forbes)
More pharmaceutical companies are utilising blended learning experiences to improve compliance, including online GMP training for employees and contractors.

That noted, eLearning is still not used extensively in the pharmaceutical and medical device industries.

Why are companies in this sector hanging on to ‘old school’ training options, especially when face-to-face training relies on everyone being in the same place, at the same time, and in close contact with others who may have been exposed to Covid?

Perhaps the main reason for the slow adoption of online training is trust.

Has the industry been fearful of the costs involved with computer systems validation (CSV)?
Has regulatory burden made pharmaceutical manufacturers nervous about 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 bigger picture, instead.

It makes a lot of SENSE to offer induction training, and refresher training, using eLearning options – with additional product-specific or industry-specific training offered virtually (Zoom-based, Teams-based, etc) – when considering convenience, accessibility, scheduling, and training management. These courses are trackable – Certificates of Completion stay on record, and GMP refresher courses keep compliance ‘first in mind.’

(Of course, you’ll need to ensure a consistent, organisation-wide compliance culture – including for data governance and data integrity compliance matters.)

GMP compliance training is also imperative if you want to maintain the compliance culture you’re creating — it reminds employees, contractors, and suppliers of their responsibilities and personal/professional liability — and with GMP compliance, and public safety — everything counts.

So why is training so important?

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 challenging.

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 and development programs also tend to pay for themselves, in terms of reduced attrition of employees — and in terms of reduced deviations and recall risks.

Professional training and development support is considered to be one of the most sought after benefits for employees seeking new roles and/or additional responsibilities.

Replacing an employee lost to attrition is believed to cost approximately 3 to 5 times their annual salary; not including the fact that, in general, it takes most professionals about 2.5 to 4 years to become proficient in a new role in a new company.

This means that 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 manufacturing plants, like the 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 4 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 GMP training so frequently overlooked, and yet so frequently a GMP audit citation?

GMP training is typically overlooked because of four main concerns:

Time
Money
Expertise
Pandemic interruptions

But most of these barriers to establishing an effective GMP compliance training program for employees, contractors, and suppliers, are fairly readily solved when utilising GMP compliance training experts and eLearning consultants.

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 GMP eLearning options as a cost-effective alternative method of training that addresses the three main concerns associated with training provision. We also offer virtual face-to-face instructor-led GMP sessions for these GMP training topics.

Let us elaborate…

1. Time

According to the 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 workday.

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 “Besides 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.“

2. Money

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 several training-and-productivity studies, including by IBM and Motorola, and as published in Forbes, CEOs really need to consider the value of eLearning options.

The research indicated that for every $1 an organisation spent on training, they benefited from $30 in productivity gains (within one to 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).

Cost comparisons: why eLearning is more affordable than face-to-face

Let’s review some case study examples of GMP training costs – comparing classroom training to online GMP training (eLearning).

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.

3. Expertise

Training and education in the pharmaceutical and medical device sectors often ends 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’s online 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 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.”

4. Pandemic risks (face-to-face training and proximity risks)

Interruptions related to the pandemic are expected to continue for years past 2021. And being in close proximity with others should be AVOIDED when possible.

eLearning allows for GMP training continuation EVEN when face-to-face is not a viable training option (although there remains an option for instructor-led ‘virtual GMP courses’ delivered via the web, such as via ZOOM), including one for Remote Auditing as well as an eLearning module covering Remote Auditing procedures and desktop-audit preparation recommendations.

There’s no silver bullet for SARS-virus contagion risks at the present time. And being near others, especially in groups, increases risks of Covid spreading to others in the training group, including increasing risks to their families, children, friends, and others they maintain contact with.

While researchers around the globe are working, day and night, on prevention measures and new vaccines, we all remain at risk during this pandemic – personally and as a business venture.

But the pandemic also means that new medicines are being developed, and trialled. Once approved, organisations making these medicines will require skilled employees for ‘ramping up’ production lines, and/or expanding production and/or distribution at a national or global level.

And these new employees may enter the sector from other industries. If these employees arrive from non-regulated industries — or return to this sector after working elsewhere — they will need a variety of GMP training courses to get up to speed.

And eLearning is the perfect solution for induction training, refresher courses, and product-specific Annexes.

Key Points – the eLearning Value Proposition (Business Case)

Downtime is minimised, keeping production running on schedule and avoiding scheduling conflicts
eLearning can serve as Induction Training for new employees and suppliers
Workforce knowledge can be brought to a common basic level (reinforcing the compliance culture)
With 12 months of access, eLearning content can serve as an ongoing reference tool for personnel
Breakdowns, lockdowns, equipment maintenance times frames can be viewed as an opportunity for personnel to complete on-demand eLearning courses or virtual GMP training
Employees do not need to be sent off-site, which often involves paid travelling time or other expenses — the 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 to help with knowledge retention
There are numerous training cost savings compared to traditional forms of classroom-based ‘face to face’ training; travel, accommodation, trainer time, facility and equipment cost, paper and materials, time away from production
GMP topic Course Certificates of Completion are generated with unique validation numbers for audit purposes; these can be stored electronically, and training is time-stamped
Self-paced increases self-confidence and reduces awkwardness — 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, and if a learner was already familiar with the topic but needed a refresher course, they can learn in less time (compared to being in an all-day class with learners who were less familiar with the GMP training topic)
Trainees are able to spend more time on concepts that aren’t familiar to them; and can move more rapidly through GMP training topics that they are more acquainted with

Why eLearning can be the best solution (Conclusion)

In many instances eLearning wins hands down over classroom training when it comes to cost, in both time and monetary value!

And with the pandemic, in terms of personnel risk reductions and reduced movement in the community (as increased movements, in a community or between suburbs, is known to increase virus transmission risks).

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.

And in the face of a pandemic — it just makes sense.

eLearning uses technology that can keep us safer — self-paced, readily accessible, on time and just-in-time training from any location — avoiding preventable exposure risks to new strains of the virus, and to potential organisational shut-downs (re quarantine requirements) and other pandemic-related risks.