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 ...

Why pragmatic, risk-based quality systems may offer a smarter path for sponsors and CDMOs than compliance theater 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 ...

The International Council on Harmonization (ICH) has issued training materials to complement its revised Q9(R1) guideline on quality risk management aimed at assisting the pharmaceutical industry in ...

Environmental contamination control is a crucial part of sterile pharmaceutical manufacturing, and risk management is essential to ensure that appropriate control practices are in place. The Risk ...

The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.

Discover how total quality management (TQM) improves product quality, streamlines processes, and enhances customer ...

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 ...

Enterprises have spent years building third-party risk programs around evidence collection, complete with security ...

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 ...

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 ...