I would like opinions on whether training should be a test step in each validation.
I am of the belief that if their is a training policy in place company-wide, which is audited on a regular basis by QA/QC, training does not need to be checked for each individual validation project.
Responses are much appreciated.
[COLOR=#333333][FONT=inherit][FONT=inherit]Jim Agalloco
http://www.linkedin.com/profile/view?id=4604445
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This is the sort of thing that contract service providers like to insert into their contracts. Ups the billable hours without a lot of added value. If the assigned individuals need additional training by all means do do, but to mandate it is just over compensating.[/color]
[COLOR=#333333][FONT=inherit][FONT=inherit]Mark Shuster
http://www.linkedin.com/profile/view?id=10450749
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I would agree and disagree with Jim’s opinion. If a firm has a well established training program covering employees and contractors, there should be no need. However, here’s a real world example.
I was an employee of a big pharma company and a quality person dinged my work once because I used a popular off-the-shelf statistical software package, but was not trained on the firm’s SOP to use said software. Didn’t even know the SOP existed, so a gap in the training program would be the root cause. But, had to do a deviation report because of it.
My opinion is there has to be some common sense. There is a point where credentials, education, and experience to perform a task supersede reading an epigrammatic SOP. But, I guess in the end, if an auditor really, really wanted to dig into it, I was out of compliance with my training of using said software.[/color]
[COLOR=#333333][FONT=inherit][FONT=inherit]Robert Lee
http://www.linkedin.com/profile/view?id=104311825
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It will help employees remain in compliance as a test script. The continuing validation will drive compliance as being untrained can easily turn into a major problem. I’ve seen to many cases of untrained people as performers and approvers a test script will help prevent this issue. A small company can manage the risk but why?[/color]
[COLOR=#333333][FONT=inherit][FONT=inherit]Rajkumar Juturu
http://www.linkedin.com/profile/view?id=226114516
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Training is an imperative requirement in a GMP world. It ensures personnel are using equipment appropriately and per the described SOPs’.
Personnel training has to be well documented and should be available at request.[/color]