Risks to a medical device’s performance can occur at any stage of the product lifecycle, as highlighted at the 2015 Risk Management Summit conducted by AAMI. Sometimes, changes in a product may be so ...

University of Colorado Boulder is committed to managing its risks proactively, holistically, and ensuring that risk management is an integral part of all university activities and a core capability.

Your risk and compliance functions are probably costing you more than they should. Not just in budget, but in drag. When your functions are siloed, they create redundant work, blind spots and a bad ...

This article is part of PharmTech's supplement "Injectable Drug Delivery." Aseptic processes are some of the most difficult processes to conduct in the pharmaceutical industry. Because of the nature ...

Criticality management combines pharmaceutical product, process, and material knowledge and risk management in one approach, which is reflected in a single document. At the end of the 1990s, many ...

If most midsize companies have a formal risk management process, why did so many fail even in pre-pandemic years? The problem is that risk heat maps — many companies’ primary tool for assessing risk — ...

According to the National Association of Corporate Directors (“NACD”), “there are number of things that Boards need to do as the number and magnitude of business risks increase.” The NACD supports the ...

What is risk? Some say risk is a nasty four letter word that can ruin your life. Risk management is serious business. As an industry, it includes over 30,000 companies and generates $6 billion in ...