By Laurel Hacche and Debra Cortner, SQA Associates ANVISA (Agência Nacional de Vigilância Sanitária) There were no updates for ANVISA for October 2020. http://antigo.anvisa.gov.br/updates China Guidances and Regulations Regulation of… read more →
By Laurel Hacche and Debra Cortner, SQA Associates Eudralex – Volume 4 – Good Manufacturing Practice (GMP) Guidelines and Annexes There were no updates noted for Eudralex – Volume 4… read more →
Association for the Advancement of Medical Instrumentation (AAMI) AAMI News: Draft Guidance ‘Leapfrogs’ FDA into Regulation of Brain – Computer Interfaces, April 2019 For people affected by paralysis or an… read more →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 →