Quality Risk Management (QRM)

iSpeak Blog
ISPE’s second virtual Global Pharmaceutical Regulatory Summit, held on 16 June 2021, brought together regulators from European Medicines Agency (EMA), Australian Therapeutic Goods Administration (TGA), US Food and Drug Administration, and Center for Drug Regulation and Research, FDA Philippines to...
Video
Complimentary Learning Level: Intermediate Session Length: 1 hour Quality Risk Management (QRM) and Knowledge Management (KM) are positioned as dual enablers to an effective Pharmaceutical Quality System. While there is...
Technical
Recently, recalls of angiotensin receptor antagonists, particularly valsartan, and warning alerts about N-nitrosodimethylamine (NDMA) impurities in drug substances such as ranitidine and metformin have demonstrated the urgent need for manufacturers and regulators to control impurities throughout...
Technical
Over the years, the roles and responsibilities of engineering and quality/validation personnel for commissioning and qualification (C&Q) activities have evolved. Now more than ever, commissioning and qualification approaches based on quality risk management (QRM) principles rely heavily on...
Training
This interactive advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to....
Guidance Docs
1 Introduction In the evolving regulated IT environment there are many things to consider when thinking of turning to the cloud for a solution. This...
Technical
This article was published in the March/April 2016 edition of Pharmaceutical Engineering® magazine. It is one of five articles nominated for the Roger F. Sherwood Article of the Year Award, all which will be posted to iSpeak throughout the week of 5 December.
Guidance Docs
Guidance for Industry, Q9 Quality Risk Management U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug...