At some point every year (or perhaps every 2 years) someone in a pharmaceutical organisation will say “It’s time to think about this year’s GMP training”. This statement will usually be received with little enthusiasm from those who hear it, but nevertheless a plan will be formed to deliver the training over the next 4 or 5 months or so. On the day of the training the majority of delegates will arrive with equally low levels of enthusiasm as the annual chore of GMP training begins. “Right – let’s make a start” the trainer will say, as the delegates think “well let’s get this over and done with” as they listen (whilst trying to stay awake) to the focus area of this year’s training – which is usually what they did so badly wrong last year!
Now this might not be exactly what happens in your own organisation, but I am sure that some elements of the above ring true. This does beg some really important questions for me. We know we have to have GMP training – but why is it generally done so badly? Is there a way in which it can be done so much better than it often is?
Of course it is not always done badly, but GMP training by its nature is going to be difficult (but not impossible) to make a stimulating topic. What is important is that you offer a course that whilst getting your main message across is done in an interesting, fun and captivating manner. If you are involved in GMP training then here are some tips for you.
One problem for GMP training is who is going to present it? Few organisations these days have dedicated GMP trainers, but some still do. Often GMP training is done by Quality Assurance personnel who, whilst very knowledgeable, may not always be the best presenters. Try and select trainers on their ability to present the material rather than their expertise. If the presentation is poor – then the message is usually lost. Focus on presentation skills first and foremost.
Vary the presentation from year to year. Don’t show the same old video that they have seen 10 times before. Remind delegates of the reasons for and importance of GMP and then focus on your particular hot topics for this year. Try and bring in case-studies and real events as much as you can.
Give delegates a mix of presentations. Remember that you can usually hold a person’s attention for about 20 to 30 minutes, so it is no good going for 2 hours of “death by PowerPoint”. People will just switch off. By all means use PowerPoint, but use this to emphasise the important points. Never simply read the slides out – the delegates can read for themselves. Trainers who simply read out sides are no good – don’t use them! Consider using a number of trainers to vary the presentations. Also think about games, quizzes and exercises. If well thought out and well explained then these do work.
You can spend as little or as long as you like. Normally anything between 2 hours and a full day is normal. I like 1/2 day sessions, as this allows you to get two sessions in during a single day. The advantage of a 1 day course is you have time to go into detail in a number of areas. With a 1/2 day session you have less time, but you can focus here on just the main points of interest. Sometimes “less is more”. With 1/2 day sessions you can go for fast moving and high impact training – getting a few important points across rather than covering an enormous amount of ground.
Alternatively you could think about doing the course over lunch time – you get more delegates with the “free lunch” offer.
Choose a good room. Try and get a room with some natural day-light, comfortable furniture and a desk to write on. The U-shaped table plan is good as it allows the tutor to interact with the delegates more as well as the delegates to interact with each other. If you have large groups then go for cabaret style (around a number of tables) – this has the advantage that delegates are already positioned in work groups for any exercises that you do.
Have a range of activities that cater for different people’s needs. Some can be thinking related, some can be problem solving related, some can be “what does it actually say in GMP” or research related. Whatever you do – get the delegates doing something!
The external trainer:
It is always worth thinking about bringing in an external GMP trainer (like me) from time to time. Whilst the disadvantage of the external trainer not knowing the ins-and-outs of an organisation this does have the advantage of the trainer being seen as a specialist expert. The subject is so important that you have brought a specialist in to deal with it.
If you select an external trainer do make sure that they can actually train! Most external trainers are actually “Consultants” and training is one of a long list of things (such as validation, auditing and procedure writing) that most Consultants say that they can do. Here is a fact for you – all Consultants can train. But during their selection ask yourself “can they train well?”
My previous experience
I am asked a lot to go into organisations to present GMP and Quality Management related courses. It will be fair to say that I am a professional GMP trainer. Without wishing to appear arrogant I should be good at it, in the same way that a professional tennis player is good at tennis! I hope that I have given you some useful tips here – I can’t give you all of my tips as this is my livelihood, but if you want to get feedback like you see below – then feel free to drop me an email (firstname.lastname@example.org). This is what feedback you can get when WE make GMP training more interesting!
- It was the most fun GMP refresher training that we have had for years. The guys that presented it were fun and enthusiastic – which makes you listen.
- Presenters presented with enthusiasm & energy – both clear, audible, articulate & entertaining throughout.
- Engaging, interactive, dynamic and relevant. Well done – the best in-house training course I have ever attended.
- Engaging, actively sought audience participation, committed and energetic presenters. A very new way of presenting GMP.
- I thought that the presentation of the training was brilliant, the trainers were very good speakers and used all the correct body language to keep people engaged.
- Usually GMP training is a sign-in and give me a nudge if I fall asleep. The presentation was really impressive and with audience participation seemed to keep everyone focused. The presenters really knew their stuff.
- The best GMP training I have attended in 12 years!
- WOW – how refreshing. This has taken GMP training to a new level.
- The trainers made it fun, thought provoking and educational – whilst at the same time were very amusing.
- This was a striking example of great presentation – I looked around and everyone was engaged.
I hope that this post is of interest. Feel free to comment below.
For more information on our GMP training click here.
Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.
Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.
While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.
About the author
Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.
Training courses on Annex 1
There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.
Our 2-day course is updated for Annex 1 changes
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