How to acquire GMP/GLP certificates?

[TBG]

Hi Everyone,

I am pretty new to this forum. I have been in academia (microbiology) in Canada, and ending my postdoc of 4 years. I have fallen out of 'love' with academia and I want to start going to industry jobs. But I have no clue where to start. I have been applying to jobs, but as so many require GMP/GLP certification or some kind of ISO certification, I wanted to know if you could recommend where to start acquiring them (whether online or in colleges?).

Thanks for you help

[Rich Lemert]

This is outside my realm, but a quick google search found the following link for the CPGP certification (Certified Pharmaceutical Good Practices [?]) from the American Society for Quality.

http://asq.org/cert/pharmaceutical-gmp

It might be a good place to start looking.

My cursory glance at this page suggests that you might have trouble filling the experience requirements the certification requires. There may be an "entry-level" certificate that you can start with.

I suggest you see if there's a local ASQ chapter near you where you can start networking. They probably also have a sub-section on GMP that might be able to point you in a more informed direction.

[TBG]

Thanks Rich, but as you said, I don't think that really helps me. There are a lot of sites for certification that I found but they look 'shady'. Maybe I am not looking for the right thing? If there is anyone out there who knows more about this, please help. Thanks

[D.X.]

Hi -

I don't know much about GMP/GLP and requirements there, but I can talk about my ICH GCP experience. (Good Clinical Practice ).

In this case Pharmaceutical Companies are responsible for documenting their GCP relevant employees are trained. How they delever that training is left to the companies - there is of variability on how the train is done, but the key principles must be covered. There is no one stop GCP certificate acknowledged by all companies. These means every time u switch companies you must go through their GCP training irrespective of prior training and conduct with a GCP relevant function. There is nothing portable certificate wise - what is portable is the experience/practice you bring - your experience is documented as per your prior employer at least for getting the job. Accepting u will be trained again within the training program / SOP of the company.

Maybe same for GLP/GMP? There are many consultancies that do provide GCP or Gxp training services to Pharma companies. The only point I guess to mention is what's the value of such training tin the absence of an environment to practice or rather implement ? There is so much in GLP/ GMP that there is no way one can be an expert in all - each function will know the areas specific to thier jobs. In the absence of prior hands on experience - the material will make want to shoot yourself as it can be so dry.

I think it best to get some top level exposure - understand key principles and run with that.

With slit of those jobs by asking for GXP - I think they are real asking more for the experience working within GLP/GMP environs more so than a certificate.

But that's just my experience from GCP where I am bridging from - maybe others can validate or disagree ?

DX

[Dave Jensen]

I would entirely endorse a strategy of networking with people in the kinds of jobs you'd later be interested in, and then jumping on coursework they recommend to get a certificate (if they even say this is necessary.) Get free subscriptions to biopharma journals like Genetic Engineering News or Biopharm International, and read through the articles. Get accustomed to the verbiage used, and gain networking contacts through their publications,

Dave

[D.X.]

I agree with Dave. Get the lingo and feel.

The other point about GCP (another one is GPhVP, Good Pharmacoviligence Practice) is that that the companies have to document the company driven training to Health Authorities especially in the case of an audit (I.e. FDA, MHRA etc) just so you know why each company has to do its own training.

[TBG]

Thanks for all the help everyone. It's good to hear about your experiences in this matter. I didn't know companies had their own specific GXP training

Cheers

[Rich Lemert]

I was just talking to someone I know who has been in this area for several years. She says the one group you should check out - it's the primary professional society for this arena - is RAP - Regulatory Affairs Professionals.

http://www.raps.org/