Showing posts with label Regulations. Show all posts
Showing posts with label Regulations. Show all posts
Sunday, February 5, 2012
Saturday, February 4, 2012
FDA and European Medicines Agency sharing work....:)
This article about sharing inspections work between FDA and European Medicines Agency. The European Medicines Agency and the United States Food and Drug Administration (FDA) are launching an initiative to share work on inspections of manufacturing sites in each other's territories. This is a three-year pilot program to share work on facility inspections - including those making finished dosage forms - in each other's territories.
Wednesday, January 25, 2012
Do I really need to know about electronic signatures in pharma industry???
Hello readers here I would like to discuss about key points about 21CFR Part11 and key words associated with it.
Do I really know about this?
The answer is ''YES'', in pharmaceutical industry computers are unavoidable at the present scenario. Whenever you use computers to generate data , you need to follow this regulations.