A PQRI expert working group provides case study examples of risk-management applications. The harmonized Q9 Quality Risk Management guideline from the International Conference on Harmonization (ICH) ...

Chapter 14: Current Good Manufacturing Practices and Quality System Design Chapter 15: Canadian Good Manufacturing Practices and Establishment Licensing Chapter 25: Components of a REMS: Communication ...

Quality management systems (QMS) have been in place since the beginning of the Industrial Revolution. They were used to manage and curtail defects in products and eventually evolved to become a set of ...

Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products, says Susan J. Schniepp, executive vice-president of post-approval pharma and ...

Total Quality Management (TQM) refers to management methods used to enhance quality and productivity in business organizations. TQM is a comprehensive management approach that works horizontally ...

Adam Hayes, Ph.D., CFA, is a financial writer with 15+ years Wall Street experience as a derivatives trader. Besides his extensive derivative trading expertise, Adam is an expert in economics and ...

Improving the quality of clinical trials is a major strategic activity for Big Pharma, one where efficient management of a demanding set of regulatory requirements can have a positive impact on the ...

Quality control takes time and money, but it can save your business significant hassles in the long run. Low-quality products can gain you bad publicity and legal sanctions, including lawsuits and ...

Rep. Kaufman, elected in House District 28 with less than 50% of the district vote, wishes to use quality management principles in improving operational and quality management systems and practices ...