Melanoma is one of the less common types of skin cancer, but it accounts for the majority of skin cancer deaths (about 75%).

One of the regulatory responsibilities of the quality control department is the release decision for drug batches into the market.

On July 8, the Food and Drug Administration (FDA) announced an initiative “… to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 Guidance for Industry Part 11, Electronic Records; Electro

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.