On May 19, the U.S. Food and Drug Administration (FDA or the Agency) published the draft guidance “Risk Management Plans to Mitigate the Potential for Drug Shortages,” which aims to assist drug ...

In cancer clinical trials, scientists are always trying to strike the right balance between maximizing data quality and minimizing cost. Here, risk management can be an extremely helpful tool, because ...

In June 2022, the AICPA’s Auditing Standards Board (ASB) and Accounting and Review Services Committee (ARSC) issued interrelated final standards on quality management intended to clarify and improve ...

PLEASANTON, Calif.--(BUSINESS WIRE)--Veeva Systems (NYSE:VEEV) today announced a new quality risk management (QRM) capability in Veeva Vault QMS. Life sciences companies can now take a proactive ...

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 ...

Drexel University’s Post-Bachelor's Certificate in Quality, Safety and Risk Management is designed to prepare health professionals who can lead organizational efforts to improve and monitor quality ...

Clinical trials can often take between six and seven years to complete, but that timeline isn’t always practical for the problems pharmaceutical companies are trying to solve. Additionally, six years ...

Total Quality Management is a formal management style premised on the notion that measurement of a finished product or project is insufficient to ensure quality. Instead, each process necessary for ...

Risk management is the process of identifying potential risks and/or harms and creating a plan to prevent the risk from happening or reduce the risk as much as possible. There are different types of ...

Unexpected expenses, a sudden drop in sales, a data breach: These are just a few examples of business risks. And knowing how to manage these potential interruptions is essential for any risk ...