Biologics

Having a good CAPA management system is a key element in making sure your CAPA process is successful. QualiPro has the functionality to manage the entire CAPA process – even those CAPAs that originate in other systems. A request can be...

After the shutdown of a major contract sterilization facility in Illinois, and another one in line to close its doors soon, FDA is worried about a shortage of medical devices. Ethylene Oxide is a widely used sterilization technique for medical products...

Happy World Immunization Week! Lately, we’ve heard about outbreaks of diseases that we previously thought were preventable. What are some of the latest numbers and what can we do? This week’s blog is a snapshot of the impact of vaccines...

In December 2018, the U.S. Food and Drug Administration formally recognized a public database that contains information about genes, genetic variants, and their relationship to disease. This blog discusses the motivation for creating such public databases and the implications for...

In contrast to 2014, news on the Ebola virus today is relatively minimal. However, Ebola outbreaks are still occurring, most recently in the Democratic Republic of Congo. This article reviews the response of the U.S. FDA to the Ebola virus...

Posted By: Stephanie Bouzounis, Senior Communications Specialist The AIDS (Acquired Immunodeficiency Syndrome) crisis in the early 1980s had a profound effect on blood donations. The perception that the blood supply was safe changed in the mind of the public as well as...

Happy New Year from EMMA International!   Your ‘one stop shop’ for all your quality, regulatory, and compliance needs.   The new year brings with it the halo of fresh starts and new opportunities.  What hasn’t changed are the usual constraints of time, budgets,...

Spring is off to a great start for EMMA International! We are beginning this spring season by offering a new, unique service to those looking to find direction for their quality and regulatory needs. If you’re not sure where you...