By Paul Smith on Friday, May 14, 2004 - 01:47 am:
There are lots of technical posts in this forum.
My question is a "child like" simple one:-
What evidence do you base an evaluation that an analyst has been well trained in HPLC ?
Most regulatory bodies for Pharmaceutical and ISO 17025 fall back on the line that the organisation must justify and defend the training and standards of technical knowledge for the laboratory and analysts.
What are your thoughts ?
By DR on Friday, May 14, 2004 - 10:44 am:
Supervisory and peer review of data are key.
New analysts are, in addition to being given short courses, trained by experienced analysts and/or supervisors on how HPLC is to be conducted within a particular lab. A common understanding of what constitutes "good chromatography" as well as the agenda of a particular lab will determine what gets emphasized in the training regimen of an analyst.
I have found over the years that there seems to be a series of errors that every chromatographer makes. Once they've made each of these errors and has learned from them, they are (IMHO) competent chromatographers. Good chromatographers are the ones who repeat said errors less frequently.
By Tim on Tuesday, May 18, 2004 - 05:09 am:
Our initial training is against an approved training module and SOPs. An "approved"/suitably experienced trainer does the training and to some extent their direct observation of the trainee is used in the assessment of their competence.
The training module has questions for the trainee to answer (answers aren't directly available from the module - they are a combination of information in the module, SOPs and trainers demostration/discussion).
There are also requirements for testing. For example the trainee has to perform a specified analysis using samples with known active content and achieve results within set limits. This is the same for experienced analysts testing different products - they have to be qualified by testing a known batch of product first.
Failure to meet the testing/training requirements results in appropriate investigation involving the trainee, trainer and management as necessary. The training module may also contain remedial actions to be taken by the trainer, such as going over problem areas, getting verbal answers to different questions, etc.