Quality Risk Management (QRM)

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
Review the purpose, elements, and implementation of quality management systems, and risk management strategies. Highlights include a review of change control, CAPA, and internal assessment programs. At the conclusion of...
Training
This online course will give participants a practical introduction to the 21 CFR Part 11 regulations, which affects many aspects of computerized systems in the pharmaceutical industry. The course will present an overview...
Training
Effective project progress, monitoring, and control are not regulatory issues, but are necessary for the efficient operation of a company and part of Good Engineering Practice (GEP). This online course considers the...
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...