In Part I and Part II<

Medical device manufacturers may gain a one-year exemption from Food and Drug Administration (FDA) inspections if their establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members usin

For quite some time, polls have indicated that public approval for Congress remains at an all-time low. Congressional gridlock is difficult to watch for U.S.

Approximately three-fourths of product safety recalls in the United States are the result of some design flaw in the product rather than a manufacturing or other defect. Most violations of the U.S.

The compliance department’s primary function is to ensure that the company complies with all applicable regulations, rules, and laws. Regardless of the industry—life science, energy and utilities, or financial services—this is a universal mandate.

The Toyota Production System and U.S. health care improvement share a long history. What lessons can health care leaders learn from Toyota’s recent production troubles?

A surgical technician prepares her back table for the next laparoscopic surgery. Instruments are removed from their containers and packages, and placed neatly on the back table.

(Academy Leadership Publishing: King of Prussia, PA) -- When news headlines trumpet story after story about fiscal mismanagement, unchecked greed, massive bankruptcies, and rampant downsizing, it’s hard to believe there’s any good news about the business world.

In the classic Aesop fable, “The Fox and the Grapes,” a fox desires some grapes hanging high overhead. When he is unable to come up with a way to reach them, he convinces himself that the grapes are probably sour and therefore not desirable anyway.

A woman in Southern California’s Inland Empire, age 53, is suffering from an unidentified neurological disorder.