C.02.006 Interpretation 5 : GMP refresher

Refresher

What a nice word! To refresh! To refresh GMP knowledge. As if they were NOT fresh… probably not indeed.

Interpretation 5 of the Canadian regulation quotes « All personnel are aware of the principles of GMP that affect them, and all personnel receive initial and continuing training relevant to their job responsibilities. »

Let’s dig a little deeper into this.

« All personnel… »

How can it be clearer? Human Performance Improvement (HPI…yep, training groups are progressively called HPI teams) personnel are frequently asked what is the target audience for a given course or seminar. Hey, we are quite lucky here : the regs dictate it!

EVERYBODY !

I did not see any explicit exceptions here. The V-Ps are included, HR is included, the finances guys too! And the Engineers (with or without the capital letters!). For those who still resist GMP training, make them read this sentence or print it in font 344 and stick it on their door next Monday morning… they should get the picture…

« …are aware of the principles of GMP that affect them… »

Ah, a little more cryptical here. (I love that word cryptical as in dark, creepy and dusty!) What are the compliance concerns linked to each and every job position. Some will proudly tell you that they have none. Oh yeah? Make an effort to find a link between their job and the regs. It is not that hard. You will then be able to justify their presence at your next GMP session and remind them that their absence was noticed last time… Upper managers and engineers beware!

The other key word is « aware ». Do we become aware after 30 minutes, 1 or 2 hours… or 5 weeks of training? Those who were kids once (!) will remember the lessons learned in the first 10 years of this intense learning period of their life. Lessons at school, lessons at home, lessons everywhere. And everywhere the same method was applied: repetition.

Repetition is the mother of all skills.

We all learned early in life that we should not cross the street running. How many times were we told before it was actually engraved in our brain? Research has shown that a kid must be told the same thing more than 15 times before long term memory kicks in the mental process to integrate the concepts with the rest of the cerebral information.

15 times.

How many times a normal and experienced adult should receive an information before it is part of his cerebral heritage? Some would say that once is enough. After all we are talking about an experienced adult, experience compensating childhood innocence for a large part… others will argue convincingly that this experience is in fact, an obstacle, a barrier to learning and that you will in fact require more than 15 repetitions to make anything stick in an adult’s brain. More than 15 repetitions, a royal enquiry and a referendum…

How much time is required before a normal adult to integrate GMP principles that affect them? This is for you to decide but read carefully the next part of the sentence…

« … and all personnel receive initial and continuing training… »

Initial : at hiring.

And continuing : ON GOING !

Not once year or biennially.

ON GOING !

Let’s go back to the street crossing example. If your parents had thought in their great wisdom that one warning was enough, you would probably not be reading these lines.

Why then, do we do this in our organizations? A good introductory training session and woosh! The trainer disappears! When I write « good », I mean this as a wide spectrum definition.  I have heard about a 30 minutes introductory GMP session. 30 minutes here, 1 h in this other organization, occasionally 2 h or even half a day. At the other end, some companies offer a 2 day orientation program… or a full week. Training overdose? Indeed! Even for higher education, lectures rarely last more than 3 h… and the students voluntarily attend…

In both cases, initial training is delivered, in compliance with the regulatory requirement. And continuous training ? Is it really necessary?

Research on fruit flies, drosophila melanogaster, has demonstrated a very interesting process for long term retention. Scientists have shown that they could affect the flies’ memory in such a way that they would remember a stimulus FOR THE REST OF THEIR LIFE! Oh, sure, they live only 3 days but still, they never forgot. How could this happen? The researchers have succeeded this feat by stimulating protein synthesis in their brain. Protein synthesis was shown to be a key element in the memorization process. This occurred only if the stimulus was repeated. Repetition was essential. But not only was a repeated stimulus necessary so was also the pause between the « learning » sessions.

Read this again : not only must the stimulus be repeated but a strategic pause or break must also be planned. We could not for example repeat the same GMP training (who would think of this!?) year after year or month after month without a time for the learner to ponder about the new concepts and think of ways to integrate them into his work environment.

The timing after the repetition is important.

Is once a year an adequate repetition pace? Probably not.

Is a whole year an adequate pause between the stimulus.

Probably not.

Certainly not.

Read the regs again :

« … initial and continuing training… »

Surprisingly this is pretty avant-garde, coming as it is from technocrats. The industry is usually well beyond the bureaucrats… maybe we have something to learn this time.

Let us go on…

?…relevant to their job responsibilities. »

This could hurt. Ideally GMP training should be designed for each specific job position after a thorough needs analysis. At least for every department. The annual refresher generally address the same compliance bugs from one department to the other. However, engineering and QA do not have the same GMP concerns. And the warehouse team would probably expedite the training session…

But I wonder : me might not be at that level of specific training. I am always quite amazed to realize that most people have a very vague idea of GMP in general, the essence of it, compared to their very deep and focused knowledge of their operations.

What if we were to spend the next few years raising the level of awareness of GMP of our colleagues? Just trying to connects the dots between the details of daily operations and the raison d’être of GMP.

You probably know that there exist several types of learning. Some people love formal lectures. They are not that numerous. Most adult learners are invigorated by a frank and honest discussion. Most participants learn at a different pace from their neighbors. The trainer, however, will train at the same pace for the whole class, as his own rhythm. The trainer cannot vary the speed continuously to please everybody’s learning type. Some tricks of the trade are available to ensure a proper learning transfer but listen to Robin William, Eddy Murphy or any other Speedy Gonzalez type of stand up comic. Slow or fast their message comes across. Ok, I admit, as far as the regulatory content, their message is rather weak. As far as the impact they have on the participant… WOW!

Re-read the precedent paragraph. What would happen if we were to spend the next few years concentrating on compliance awareness and with the same impact as a Robin Williams’ number. What if we were to affect our internal clients, employees and colleagues to make sure they all have compliance at heart? Compliance for the right reason: protect the public.

Oh?… some people will be surprised to learn or re-learn that this last statement is at the heart of our industry. Amidst the latest scandals and recalls due to diethylene glycol in Panama and China, the pharmaceutical industry still has public safety has its number one goal. Interesting concept, isn’t it?

Ask any group of employees from any pharmaceutical company to find 5 simple solutions to improve performance as far as compliance is concerned and you will have a winning number. Supply the same group with a recent copy of the regulations and add a rule to the game : find specific elements in the regulations to support their ideas for improvement and BINGO!

CONTINUOUS IMPROVEMENT 101!

We usually take new year resolutions in January. I know for a fact that some countries in Asia celebrate the new year in the spring. Let’s celebrate the GMP new year now. This is especially true in Canada in 2009 as the new regulations just came out.

So… GMP resolutions… here we are!

I will design a GMP training that will touch every employee’s conscience while educating them about the role and importance of our industry.

I will plan for continuous training, all year long.

I will stop making typographical mystakkes…

Hmmm. #2 looks daunting to you? Why not organize a teleconference with a few colleagues or invite them for lunch and brainstorm about it… or plan for 15 more minutes at the end of your coming GMP refresher and ask… the audience! THEY will tell you what they would like to know about GMP. Or google GMP training, GMP training game or some other variation.

Until next time, make a difference!

Have fun, learn well

and stay compliant!

Par François Lavallée, M. Sc.

 

N’HÉSITEZ PAS À LE PARTAGER pour inciter vos amis à penser autrement!

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