All Features
Carolyn Clancy
Walk into many stores and you’re bound to be impressed by the quality of digital cameras, TVs, cell phones, and other consumer electronics. Every year the quality of these devices improves by leaps and bounds, and consumers often pay less as products improve.
I wish the same could be said about the…
In June 2007, the U.S. Food and Drug Administration issued the dietary supplement current good manufacturing practice (CGMP) final rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and…
Walk into many stores and you’re bound to be impressed by the quality of digital cameras, TVs, cell phones, and other consumer electronics. Every year the quality of these devices improves by leaps and bounds, and consumers often pay less as products improve.I wish the same could be said about the…
Sharon Phillips
In June 2007, the U.S. Food and Drug Administration issued the dietary supplement current good manufacturing practice (CGMP) final rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling…
Sharon Phillips
In June 2007, the U.S. Food and Drug Administration issued the dietary supplement current good manufacturing practice (cGMP) final rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling…
A thorny question lies at the heart of meaningful health care reform. How much is human life worth? New research from Wharton and Stanford based on Medicare kidney-dialysis data shows that the average figure—$129,090 per additional year of quality life—is higher than prior studies have shown.…
David Ade
For companies doing business in regulated environments, the benefits of implementing software systems are abundant. Improved product safety, higher quality, enhanced efficiency, and increased probability of maintaining regulatory compliance are just a sample of the numerous benefits…
Carolyn M. Clancy M.D.
If you’ve ever watched the popular “MythBusters” program on the Discovery Channel, you know that many supposed truths are based on old, incomplete, or simply incorrect information.The same can be said about beliefs about the quality of health care in America. How many times have you heard that more…
Ken Peterson
From the perspective of the U.S. Food and Drug Administration and other regulatory agencies, corrective and preventive action (CAPA) is viewed as the central component that affects all control points including design controls, production and process controls, records and documents change controls,…
Patricia C. La Londe
Cardinal Health Alaris Products, which makes pumps and disposables used during infusions, was in critical shape in the late 1990s and needed to address improvement on all fronts. The prescription included improvements in customer satisfaction and in the company’s finances, which required the…
MasterControl Inc.
The advantages to pharmaceutical companies of using electronic solutions to modernize their paper-based or partially electronic processes are enormous. Automation speeds up and connects all interrelated processes (corrective and preventive actions, customer complaints, audits, deviation…
Bill Kalmar
Advancing into that mystical category of “senior citizen” brings with it certain perks. Simultaneously becoming a senior citizen, retiring, and joining the ranks of Social Security recipients is a financial trifecta.I retired in 2003, and when I made that phone call to add my name to the millions…
Tim Lozier
In today’s quality management systems, the ability to control and correct processes is key to maintaining a high level of compliance within an organization. Whether it’s tracking incoming customer complaints, identifying nonconforming materials from production, or using corrective and preventive…
Mike Richman
Dr. Tomas Gonzalez, senior vice president and chief quality officer for Valley Baptist Health System of Harlingen, Texas, is a busy man. Not only does he direct quality process improvement at Valley Baptist’s two hospitals, he’s also a physician and a certified Master Black Belt. Valley Baptist…
The cost of poor quality in health care ranges from 30 to 60 cents of every health care dollar. Until recently, however, there have been few financial consequences for health care providers’ failure to address the underlying root causes. This article describes Medicare’s new policy of not…
Georgia Institute of Technology
Research reported recently in the journal Advanced Materials describes a potentially promising strategy for encouraging the regeneration of damaged central nervous system cells known as neurons.The technique would use a biodegradable polymer containing a chemical group that mimics the…
Abby Vogel
Tushar Sathe holds a vial of dual-function beads embedded with iron oxide and 600 nanometer emission quantum dots, while Shuming Nie looks on. The other vials contain beads embedded with quantum dots that emit light at other wavelengths. photo by Gary Meek…
Georgia Institute of Technology
For people with impaired mobility and reduced ability to sense injury, the risk is high for pressure ulcers that can develop when they sit or recline in one position too long or wear a poorly-fitted prostheses for an extended period.
Clinical data collection helps drive the researchers’…
This figure shows the 3-dimensional dose distribution of the prostate upon completion of implanted seeds. Based on patient tests, Lee’s inverse planning system uses 15% fewer seeds. Photo by Eva Lee A California medical software company has launched…
CardioMEMS engineer Michael Fonseca uses a laser to separate pressure sensors in the company’s clean room facility in the ATDC Biosciences Center located at Georgia Tech’s Environmental Science and Technology Building. Photo by Gary Meek After…
Georgia Tech student Ashley Palmer, Ph.D., conducted experiments to validate a new cartilage-imaging technique developed by associate professors Marc Levenston and Robert Guldberg in the Georgia Tech School of Mechanical Engineering. On the computer…
Despite the best efforts of pharmaceutical manufacturers, drug labeling is one of the greatest challenges in clinical trials, involving a complex, time-consuming process to meet strict regulatory requirements and obtain wide-ranging approvals from individual countries. That labels must…
Researchers Mark Prausnitz and Robyn Schlicher use a confocal microscope to study cells whose membranes have been opened by the application of ultrasound. Georgia Tech Photo: Gary Meek Researchers have shown how ultrasound energy can…
James M. Anderson
An ABC News/Washington Post survey in 2003 found that for the first time, 54 percent of Americans were dissatisfied with the overall quality of health care in the United States. In 2006, the Commonwealth Fund released results of an international survey that measured 37 areas of quality…
Research engineer Phil Santangelo works in professor Gang Bao’s cell culture facility in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University in Atlanta. Photo courtesy of: Phil Santangelo…