Hi,

We are into injection molding for medical devices and am looking for training videos on ISO 13485 and cGMP concepts.

Searched the forum but could find a single post, http://elsmar.com/Forums/showthread.php?t=10464 but that didnot give me the intended results.

Can someone let me know websites or any source from where I can buy these ?

:thanx:

Here is a link to the Australian Therapeutic Goods Administration (TGA) (http://www.tga.gov.au/docs/html/webgmp.htm). They are the body within Australia that regulate medicines and medical devices. There are some links to GMP audits and practices that may benefit you. My company no longer produces medical grade goods but when we did we found the TGA fairly helpful. There may also be some helpful links contained in their sister site at the Australian Pesticides and Veterinary Medicines Authority (APVMA) (http://www.apvma.gov.au/qa/subpage_qa.shtml) as we dealt thru them and had to pass GMP standards.
I hope this helps.

Thanks Greg. TGA website is definitely an useful tool but I was looking more from the videos where the operators can understand better.

Action speaks better than words :D

Last year we purchased a training CD (complete with certificate at the end) program for ISO 13485 training from The ISO Store (www.the9000store.com (http://www.the9000store.com)), and it has been very useful. It is interactive so that the person receiving the training must answer little quizzes along the way before proceeding to the next screen. It's not a video, but it can be considered an option.

As for the cGMP training video, you might try the FDA's website and see what they have available. Also, another option is the GMP Institute (www.ispe.org) (http://www.ispe.org). There may be training tools available for purchase on their site.

I hope this helps. Good luck! :cool: