I am looking for advice on regulatory expectations for training records. This question is in reference to Good Laboratory Practice (GLP) training. I work at a pharmaceutical company wanting to replace yearly instructor led refresher sessions with continuous education formats. The continuous formats can be informal and difficult to track.

The regulators have done a great job stating that they want records but less so in stating what they want.

I saw the FDA had an example of an SOP they use for a laboratory - I think it was in their CDER section..........why not take a look at that and see what jumps out at you.

Informal learning is inherently difficult to track and record. Indeed, recording it can inadvertently kill off the willingness of more experienced staff to share their know how. That said, are they teaching best practice or "this is how I did it when I was a lad." - without some guidance and ongiong training would be trainers/coaches can do more harm than good. Perhaps a reasonable starting place is define what steps you are taking to ensure those of your staff who give informal training have all themselves been trained NOT in content but in how to be a trainer.

Also, training is more than a regular dose of GCP otr GLP for that matter so remember to build in mechanisms for evaluating what has been learnt NB regurgitating reams of SOPs verbatim does not mean that staff know how to apply them in practice.

Getting people to write and then critique SOPs is an effective way of improving understanding.....have you ever tried to write an SOP for making a cup of tea and then get someone else to follow it? 'tis very instructive!

In reality, learning always takes place at the point of implementing a new process....seldom before!

Monty

Janis: The FDA requires that you keep evidence that the employees have the training they need to perform their duties in the areas that are affected by the regulations. Before or during changing to continuous education format,check how many changes an SOP have during a period of time (6 months, 12 months only choose few of the SOPs') also find out, what is consider a big change and what is not.This will give a close picture of the task ahead.
Meet with managers and directors, QA/QC people and find out what are their thoughts, ideas and inputs about this matter, share with them the findings and your ideas. Prepare a "tentative" flow chart of the tracking process in mind and show it to them too.If possible do benchmarking with another companies. Once you have all this develop a plan on how to keep track of the continuous education and do it in a way that is very visible at all levels, this will help with commitment and involvement. Last but not least check http://www.FDA.com.
Ines Serra
Comunica Solutions, LLC
Bilingual trainings, helping to reduce cultural and language gaps.