GMP Training

[RR1]

Please could you tell me which staff groups you normally give annual GMP training .

Currently we do our lab (Haem and Blood bank) and our hospital drivers. I also send the current presentation to the Path IT manager, Transfusion Practitioner and Path Services/QM.

Next year for our lab folk we will be using the ORAS gold site for the GMP.

Are there any other folks I should be covering with this training?

Thanks!

[Fluffy agglutinates]

Hi Rashmi,

I work in NHSBT & everyone, everywhere has some level of GMP training or awareness. This is taken from our intranet - it might help a bit!

What Training is required?

There are three levels of GMP knowledge required by NHSBT staff:

GMP Awareness - delivered as part of the Welcome Day for New Starters*

GMP training for non Manufacturing/Manufacturing staff

Update Training

* Members of staff who work in GMP areas should also receive an Introduction to GMP before they commence work in GMP areas.

The level of GMP training suitable for any post is determined and approved by Quality Assurance, according to the nature of the job. All training materials are approved and monitored by the Quality Assurance department. Refer to MPD14 – Management of GMP Training for further information. All records of GMP Training must be recorded on GMP Training Record FRM14. Each Member of staff must maintain their own record and ensure that it is available for review by their manager.

[RR1]

Useful extract Fluffy-thanks! , I hadn't defined the different types of GMP training we give- so will include on the next update of our training sop. Do you perform update training using examples of lab problems or just give a condensed version of the initial training?

[Fluffy agglutinates]

Glad it was of use to you!

This extract is taken from our 'how to update your GMP' page

'Update Training

Examples of how update training can be achieved:

• Participation in the investigation of an adverse event/audit finding
  
• Update modules – refer to Management Process Description
  
• Re-completion of 6 modules
  
• Completion of GMP - General Training Modules available on Training Tracker.
  

All records of GMP Training must be recorded on GMP Training Record FRM14. Each Member of staff must maintain their own record and ensure that it is available for review by their manager.'

However I don't particularly like the way our training is carried out! It's way too generic for me, I think people respond & understand much better when it's linked to their own area - I like your idea of using 'real events'. You could get lots of different angles on that from each person. I think repeating the original stuff just switches a lot of people off...

We use something called training tracker which is basically read the info & then answer a short quiz afterwards. The passmark is 80%. I don't think it lends itself to effective training but hey-** that's what we do!

[STDUFFY626]

Our cGMP training is offered through scheduled classes for the first 3 quarters of the year and online training which covers the exact same material as in the classes. It is overseen by QA and has been made a mandatory reqirement for all job descriptions from our CEO on down the line to all staff. The benefits have been employees who have non technical jobs become additional eyes and ears in reconizing problems before they become crisis situations.

[Fluffy agglutinates]

For some strange reason the language police have asterisked my 'heyho'. Are the last 2 letters of this considered offensive? How bizzare.

[Malcolm Needs ☆]

However I don't particularly like the way our training is carried out! It's way too generic for me!

Personally, and I'll probably get into BIG trouble for posting this in public, I think that ALL of our national SOPs are way too generic to be of any use whatsoever for training.

:explosion:explosion:explosion:explosion:explosion

[RR1]

Our cGMP training is offered through scheduled classes for the first 3 quarters of the year and online training which covers the exact same material as in the classes. It is overseen by QA and has been made a mandatory reqirement for all job descriptions from our CEO on down the line to all staff. The benefits have been employees who have non technical jobs become additional eyes and ears in reconizing problems before they become crisis situations.

I'm impressed STDUFFY626- you have your CEO involved as well!!!! Sounds as though you really have this well controlled- did it take long to get buy-in?

[RR1]

Each Member of staff must maintain their own record and ensure that it is available for review by their manager.'

Do you find that your staff actually do this?... roll on another few years and hopefully this will be second nature to everyone in the UK.

Be careful Malcolm- as punishment they might 'volunteer' you to revise and condense the SOPs !!!!!

[Malcolm Needs ☆]

Be careful malcolm- as punishment they might 'volunteer' you to revise and condense the sops !!!!!

They know better than that Rashmi.

I've always been known for my verbosity.

For "condensation", read "expansion" x 10 to the nth degree!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

:D:D:D:D

[Fluffy agglutinates]

A lot of our lab staff use e-KSF to record their training. I find this very useful. Unfortunately an awful lot of people do not use this for a variety of reasons! Lab staff at least have a 'named' folder where all their training records should go. Hopefully it's all tied together with a yearly PDR...

It's very difficult to get people to understand that they have to be responsible for their own training isn't it! Very similar to CPD (You mean I have to do it myself? etc, etc)

Malcolm - completely agree with you. These national documents are a complete joke! When I first started the SOPs had a nice story at the begining explaing WHY you needed to do the task followed by HOW. A much more satisfying approach when being trained I think.

[RR1]

I have attached an extract about Good documentation practice that we have used for this years GMP- if of any use.

GMP_docs BBT.ppt

[Fluffy agglutinates]

Thanks Rashmi, I really like this!

[RoseM]

Please could you tell me which staff groups you normally give annual GMP training .

Currently we do our lab (Haem and Blood bank) and our hospital drivers. I also send the current presentation to the Path IT manager, Transfusion Practitioner and Path Services/QM.

Next year for our lab folk we will be using the ORAS gold site for the GMP.

Are there any other folks I should be covering with this training?

Thanks!

Hi, I am an Educational Coordinator in Transfusion Service and i am currently conducting the Annual cGMP training as required by the FDA. QA needs to approve the training materials. All new hires are required to attend the Introduction to cGMP which our department developed.

For the annual training, i pick a hot topic e.g. Documentation, Equipment Maintenance and QC etc. I start with a discussion on the related GMP regulations, identifying GMP elements violated and their consequences. I started this year with a pre-quiz focusing on the actual reported events and ended the training with discussing corrective and preventive actions for the events discussed...and then a post quiz.

[RR1]

Thanks for your input RoseM, I like your idea of using CAPA actions as part of your training discussion.

[RR1]

Have attached the GMP presentation we used this year (from which the documentation extracts were from)- if of use to anyone else. May be others could also share their ones so we can build up a good pool to mix and match for next year?

Many thanks!

GMP2010 BBT.pdf

[Fluffy agglutinates]

Thanks Rashmi, this is a fantastic presentation!