GAMP 5 - any good websites?

COMPUTER SYSTEM VALIDATION (CSV)
1

Can anyone recommend a good website/reference source for reading up on GAMP 5?

I have found a few sites that have a short description of the differences from GAMP 4 and the philosophy behind the latest version, but nothing in real depth.

I would like to buy the guide, but as a self-employed Validation Consultant “between contracts” and some-what skint at present I cannot afford the $400-odd dollars to buy the GAMP 5 guide from ISPE.

I am finding that I am losing out on possible contracts because I have no experience of GAMP 5, experience of GAMP4 is considered as no longer good enough!

Thanks

2

I find it surprising that you are losing jobs because of this, I think that if you are a member of the ISPE.org website then it shouldn’t cost 400 bucks.

I have read GAMP 5, its not exactly a GAMP 4 re-write, the one major thing I took from it was that “Leverage off vendor documentation whenever possible”.

Also have a look at our GAMP 5 article it should offer more insight

http://www.askaboutvalidation.com/featured_articles_expanded.php?uid=31

Hope this helps

3

I agree with Graham. You should not be losing clients because of GAMP 5 - maybe in a year or so.

Try here too
http://www.hlsinnovations.com/gamp.html
.

The secret sauce, however, is still in the guide!

4

I am afraid with the scarcity of validation jobs in the UK, not knowing GAMP 5 is already a disadvanage! I have been turned down for a couple of validation contracts in the last few weeks for this reason.

I don’t know how healthy the validation engineer contract job market is in the rest of the world, but in the UK it has been very bad this year.