AlfaNordic's customized training

On a general level, it is part of AlfaNordic’s strategy to be a knowledge company, and a natural starting point of this is to train and educate our customers. In the industry, we see a need and a request for continuous on-the-job training and upgrading of skills so the demand for training and education is increasing. Being able to offer training at a high technical and professional level is indeed a high priority with AlfaNordic. The training is always closely bound to the practical way companies work within GMP, so that the training does not constitute a theoretical discussion of section and clauses alone. Christian Ilsøe conducts training for AlfaNordic himself and tells us about the thoughts behind the company-tailored courses held by AlfaNordic.


Who is it primarily that you teach?

Our training activities have developed into something that we do for a great number of our customers. These include customers who are manufacturing pharmaceutical businesses but also companies who are suppliers to the pharmaceutical production, for example suppliers of machinery. The GMP rules also specify that the companies who deliver to the pharmaceutical industry must also have knowledge of GMP.


What are the courses that AlfaNordic offers?

We have made a course catalogue. It comprises 10 courses that are ready to be used as concept courses with a lot of training issues, but these courses will be adapted to the individual customer every single time. We offer courses in for example basic or extended GMP, good validation practice, good distribution practice, medical equipment, risk assessments and cleaning validation. We can offer these courses because we have, over the years, worked extensively with these areas and collected and gained a vast amount of knowledge.

A lot of the courses were started by some of our specialists getting up in front of the rest of the consultants at AlfaNordic and giving a talk of, say, 3 hours’ duration. Based on this, we decide that the topic is interesting and the training material sufficiently professional so that we want to offer it to our customers.


How are the courses structured?

Conceptually, they are built over identical templates with a good mixture of theory, practice and exercises. Most of them are half-day courses – that is at least what we recommend. This is simply based on the thought that very few people can stand attending a course for a whole day. If our customers express a wish for more, we would rather turn up 2 times for 4 hours than 8 hours in a row.

A 4-hour course is typically structured with 2 sessions of 1 hour each during which we draw up the framework for what existing laws stipulate, how it is doable in practice, and we may add some background on how this has developed over time. Following this, we have a session on what is new. Very few of the people attending our courses are beginners. These are people who have worked in the industry for many years. That is why we focus on a refresher of what has happened within the last couple of years, what to pay attention to and what the authorities focus on.

During the last hour, we discuss examples from the business itself. Prior to holding the course, I have obtained a lot of documents from the customer, and I show the attendees the various things I have found, and we then have a discussion on these issues. What is right and fair? For this last hour, the team is on and I am the facilitator. This works really well.


Do you conduct courses that are not included in your course catalogue?

If the topic falls within AlfaNordic’s activity area, we are happy to prepare relevant courses. We have done that before.


How many people can your courses accommodate?

We recommend a maximum of 20. Aiming at achieving a really good dialogue, our preference is about 10-12.


What is the price of a course with AlfaNordic?

In the order of DKK 14,000 – 18,000 for a half-day course. Depending a little on whether the course is a full 4-hour course and covers other issues. If the customer enrols 10-12 employees on our course then this means that the training will cost between DKK 700-1,000 per participant. That is inexpensive if you compare it up against the resources that the company would have to spend on drawing up similar course materials. The reason why we can maintain these relatively low prices is that there is a certain degree of reuse in the first 2 hours. And beyond that, we are extremely interested in pursuing our training activities, – so the price must therefore be attractive.


How many of you at AlfaNordic conduct courses?

At the present time, I would say that about 6-7 of AlfaNordic’s consultants are out there conducting training, and we are in the process of expanding that. Some people hate teaching so they are of course excused. The consultants who want to try it are allowed to try it on the internal training first. It is not just about having an extensive technical knowledge. You also have to be able to communicate. After that, they join one of us who has tried it numerous times when we visit a customer. So we don’t just send somebody out who does not have training experience, we know that he or she represents our public image.


How does AlfaNordic develop its courses?

One of the things that we pay a lot of attention to is the feedback we get from own consultants as to what goes on in the companies right now – what is popular and of interest these days. Courses like serialisation and risk assessment were developed as a result of this. We hear from our consultants that these issues are really in demand. We may also at the same time have a feeling that the customers find it difficult to interpret and translate the rules in these very areas into something they can use in practice. The rules are not spelt out. In many instances you have to interpret and translate the rules yourself. This is when courses can be very useful and consulting houses very good because we see the problems that many different companies are faced with.

We also make a point of not just going through hundreds of slides in 4 hours. There is time and opportunity to go off on a tangent if that is needed. We have all tried to attend courses where somebody literally reads the text on the slides or the legislature text, and that simply sends people to sleep. That is why we hold GMP courses that comprise the correct elements from the GMP rules, but where we at the same time discuss a lot of practical examples from the department we are conducting the course for, spiced with stories from the real world of what is good and what is inadequate GMP. In this way we generate a really good dialogue on GMP in practice, and it is at any rate our experience that this is where we are successful. All this is done in a way that we avoid hanging somebody out to dry if that somebody has for example filled in a form incorrectly.


Do you have other ways of making the training more interesting?

I always try to tie it over to something different from the specific rules we are talking about. People thus get a picture of how things are interconnected at other levels, it is not just something they are addressing in their own company. It is about traceability. It has something to do with documenting and something to do with securing a certain quality. The response I get to this is really good. They never forget those GMP courses because the examples make it possible for them to tie it over to something else – it is not just something to do with medicine. There is a higher point to it all.

When you have been teaching for many years you find out that human beings are different. Some people sit on the edge of the chair and are all keyed up. And then there are the participants expecting that what is coming is the most boring thing they have ever been exposed to. If you can turn this last category around then everybody will benefit. So we try hard to reach such a situation.

It is often a question of people believing they have nothing to do with GMP. At one point, I was asked to teach the gate keepers at a company. They had no idea why they were taking that course because in no way did they work with GMP. I fairly quickly brought up 4 examples of contexts in which they were working with GMP. For example, their jobs entailed receiving complaints outside of regular working hours. In this connection, it was their responsibility to call the quality manager and inform him/her of the complaint. The ultimate consequence of the complaint might mean withdrawal of a medicinal product. This is an extremely high degree of GMP. They furthermore performed duties as fire guards, and in this capacity they had to, once every 24 hours, read off a freezer containing samples. The temperature had to be noted down in a logbook. This is also GMP. So that people who work in a pharmaceutical company and believe that they have nothing to do with GMP, they are often mistaken. They almost all have a degree of GMP in their work.


Should a company worry about concrete examples from a course being spread out in the industry?

No, that will not happen. Nobody ever discusses product and/or process secrets. First, it is our company policy that what we hear in one place is not shared with others at a specific level. We can do it at a more abstract level, and that is okay. We never mention the names of other companies. Beyond this, we have made a non-disclosure agreement with the vast majority of our customers and this simply means that we cannot share anything with anybody.


How do you handle non-disclosure agreements, at the same time making sure that you contribute to knowledge sharing in the industry?

The most important thing you can do as a consultant is to spread knowledge. If we see a company doing something smart then we want to pass it on to another company when we are asked whether we have knowledge of smarter methods. We have a way of handling this which is acceptable. If I am asked about something to which I have heard of a smarter solution, then I explain that I know someone who might be able to help. I don’t say any more in this context, but I go back to the person I talked to earlier about the problem and ask whether it will be okay for me to pass on his or her contact data. People may then decide for themselves to which level they want to make a statement. I have just arranged the contact, and I know that this is approved of.

We in the industry have seen the great advantages of sharing. The risk that the industry faces is that you either place yourself below level or that you place yourself way too high in relation to the reasonable and correct level. In the first case you risk a warning, and in the other case you end up using way too many resources. So when we are talking about how to interpret GMP rules, my experience is that knowledge is shared fully openly.


Are courses used for testing employees?

I have never heard anything to indicate this and I myself have never been asked questions about something like that. The managers know the people they are employing, and I find out nothing new that they do not already know.


How do you avoid hanging someone out to dry when you point out concrete examples from the company?

It goes without saying that it may not be a pleasant situation at first when you are sitting in a forum and your name is mentioned on an incorrect document, but I make a virtue of not hanging anybody out to dry. We do this exclusively so that we can all learn something. I always make sure that the atmosphere in the room is relaxed and open before we get to that part of the course. So far, I have not been in a situation where somebody has felt that he or she has been hung out to dry. What goes on in that room stays in that room. I do not go further with the issues that are addressed. It is about learning and that is what we concentrate on.


Do you have to pass a test on the courses?

We usually conclude the courses with a test. The test is at a level that has been agreed upon with the customer. Some companies want a test where you have to, for example, give the correct answer to 10 out of 13 questions in order to receive your course certificate. We have had examples of that. Other companies want us to hand out some questions which we then discuss in plenum. Then all attendees receive a course certificate.

The course certificate is essential because the GMP rules specify that you must be able to document the training you have attended.

de én gang i døgnet aflæse en fryser, som indeholdt prøver. Temperaturen skulle noteres i en logbog. Det er jo også GMP. Så folk som arbejder i en farmaceutisk virksomhed og tror, at de ikke har noget med GMP at gøre, de tager som regel fejl. De har næsten alle sammen en flig af GMP i deres arbejde.


Should a company worry about concrete examples from a course being spread out in the industry?

No, that will not happen. Nobody ever discusses product and/or process secrets. First, it is our company policy that what we hear in one place is not shared with others at a specific level. We can do it at a more abstract level, and that is okay. We never mention the names of other companies. Beyond this, we have made a non-disclosure agreement with the vast majority of our customers and this simply means that we cannot share anything with anybody.


How do you handle non-disclosure agreements, at the same time making sure that you contribute to knowledge sharing in the industry?

The most important thing you can do as a consultant is to spread knowledge. If we discover that something is being done that is smart in one company, then we would like to pass it on to another company when asked if there are smarter methods. We have a way of doing that which is acceptable. If I have been asked for something that I have heard.

Facts

Vi udbyder både åbne og firmatilpassede kurser. De åbne kurser er for individuel deltagelse, hvor der er mulighed for at møde folk på tværs af virksomheder & uddannelser. De firmatilpassede kurser er specialudviklet i samarbejde med den enkelte virksomhed

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