Quality Risk Management (QRM)

Training
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...
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
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,...
Training
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...
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...
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 highly interactive, 3 day advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM....
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.