Quality Risk Management (QRM)

Features
ISPE held an Expert Xchange on 18 January 2022 entitled “Risk-Based Decision Making: Advancing the Integration of Quality Risk Management (QRM) and Knowledge Management (KM).” The session included presentations and interactive exercises that generated new and useful insights into the current effectiveness of the knowledge that flows into QRM and how a knowledge map can be used to diagnose...
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 share their insights on application of quality risk management. They discussed the positive...
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 the product life cycle to ensure patient safety.1
  • 1US Food and Drug Administration....
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 engineering and the application of Good Engineering Practice (GEP) to provide documentation for the...
Training
This interactive advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to current challenges and provides hands-on experience with preparing for and facilitating risk assessments.
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...