Association for the Advancement of Medical Instrumentation (AAMI) AAMI News: Draft Guidance ‘Leapfrogs’ FDA into Regulation of Brain – Computer Interfaces, April 2019 For people affected by paralysis or an… read more →
Wins & Challenges Out here in Los Angeles, we’re used to summer weather starting around now, but I still find myself reaching for a jacket every morning. Despite our lack… read more →
European Federation for Cosmetic Ingredients (EFfCI) No updates noted for EFfCI Good Manufacturing Practice Working Group. Click here for more information European Medicines Agency (EMA) Regulatory Science to 2025… read more →
China GMP WHO Statement on Rabies Vaccine Incident in China: 25 July 2018 The World Health Organization (WHO) fully supports the China National Drug Administration’s (CNDA’s) actions to withhold problematic… read more →
Wins & Challenges I usually end up writing these articles while flying. I find it peaceful, and for some reason being on a plane lets me open up my mind.… read more →
United States Food and Drug Administration (US FDA) Guidances Use of Electronic Health Record Data in Clinical Investigations: July 2018 US FDA has published a guidance for industry entitled Use… read more →
European Federation for Cosmetic Ingredients (EFfCI) European Federation for Cosmetic Ingredients (EFfCI) Good Manufacturing Practice (GMP) for Cosmetic Ingredients, Revision 2017 This document incorporates existing GMP principles, World Health… read more →
Wins & Challenges With summer quickly approaching, 2018 is flying by, and there are lots of interesting things happening within SQA. Our company is bursting through yet another record year… read more →
Wins & Challenges I’m happy to write this article during an incredible time of the year – a time when nations around the world compete in the Olympic Games. As… read more →
Wins & Challenges I’m writing this as I fly to Colorado to see my daughter for her sorority’s Father/Daughter weekend. My alma mater, the University of Southern California, is playing… read more →