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 ...

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 ...

Business risk management (BRM) is the structured process by which an organization identifies, assesses, manages and monitors internal and external threats that could impede its ability to achieve ...

Key steps for organizations and their counsel to take and issues to consider when developing and implementing a risk-based due diligence program for investigating third parties in commercial ...