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 ...

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 ...

Elemental impurity risk management can help biomanufacturers to maintain regulatory alignment and ensure patient safety.

Learn how to use risk management tools and techniques to streamline medical device and diagnostic product development. Additionally, ensuring compliance with QMS requirements and guidances for ...

Environmental contamination control is a crucial aspect of sterile pharmaceutical manufacturing, and risk management is needed to guarantee that the necessary control procedures are in place. The risk ...

Please define the meaning of “risk” from the perspective of environmental monitoring. Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with ...

Figure 1. Medical device companies exhibit varying responses to ideal complaint closure time. Strong management support can ensure that closure time is as efficient as possible. However, complaint ...

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 ...

Quality management (QM) is ‘the coordinated activities to direct and control radiotherapy procedures with regard to quality. The main aim of quality in radiotherapy is safe and effective treatment. In ...

Risk Management is the process of identifying, assessing, and prioritizing risks followed by the application of resources to minimize, monitor, and control the probability and/or impact of adverse ...