Editor's Note: "Rebalancing Quality Priorities" is a three-part series describing a new approach to quality management from a customer and risk management perspective that involves the entire ...

No medical device is without risk. And, in the manufacture of medical devices, risk management cannot be taken seriously enough. Failures can have far reaching impacts on the health and safety 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 ...

Editor’s note: This article is the first in a series to help practitioners learn about the AICPA’s new quality management standards and prepare to implement them. In June 2022, the AICPA’s Auditing ...

While security threats evolve and challenges to managing organizational risk become more seemingly every year, the foundation of securing the business is knowing and understanding its vulnerabilities ...

For all the attention artificial intelligence commands, one fact remains stubbornly consistent: Between 85% and 95% of AI projects still fail. Not because the technology is immature, but because ...

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles. A published paper, titled “Quality ...

Dr Rao is currently teaching risk management in the institute of Insurance and Risk Management (IIRM). A career banker with Bank of Baroda, he held the position of General Manager - Strategic Planning ...