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...
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...
We need to stop just talking about risk, and get serious about actually developing effective risk management tools.
The pharmaceutical industry and its regulatory agencies view risk through the very narrow lens of ICH Q9 – Quality Risk Management...
The acceleration of change, bio pharmaceutical process development and technology transfer into commercial production facilities continues to be a challenge to those involved in facility build projects in BioPharma. How...
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...
Applying the principles of ICH Q9 (Quality Risk Management) and ASTM E 2500-07 ensures GMP facilities and equipment are: "fit for use," perform satisfactorily, and may be used in the manufacturing, processing, packaging...
Right now the pharma industry needs quality risk management (QRM) advice that is focused, tried and proven useful, to save time, effort, and ultimately cost. Overcome reticence in applying QRM. Learn how to document it...
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...
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...
This interactive advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to....
