All Features
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…
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…
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,…
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…
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…
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…
John Toon
Georgia Tech professor Zhong Lin Wang holds a sample nanowire array that can be used to power nanometer scale devices. Georgia Tech Photo: Gary Meek Researchers have developed a new technique for powering nanometer-scale devices…
T. J. Becker
In our increasingly wireless world, the air is chock-full of electromagnetic signals carrying data from one place to another. Yet, while new wireless technologies advance our options in security, commerce and entertainment, they also produce interference that may cause problems for…
Georgia Tech postdoctoral fellow Jean-Francois Masson holds a microelectrode modified with a biosensing layer capable of measuring adenosine triphosphate (ATP), a chemical involved in energy transport in humans. It’s of interest to medical…
A worsening epidemic of sophisticated antimalarial drug counterfeiting in Southeast Asia and Africa is increasing the likelihood of drug-resistant parasites, which yield false-positive results on screening tests and risk the lives of hundreds of thousands of malaria patients—mostly…
Jane M. Sanders
A newly developed family of biodegradable polymers has shown potential for use in intracellular delivery and sustained release of therapeutic drugs to the acidic environments of tumors, inflammatory tissues and intracellular vesicles that hold foreign matter. These polymers have several…
Tom Solon
Advancements in diabetes treatments By any measure, diabetes is a huge health problem. Approximately 16 million people in the United States have diabetes, and it’s a leading cause of associated medical conditions such as blindness, circulatory problems and digestive disorders. While…
Christopher Werner
Although conventional homogenization has served the needs of the dairy industry and other industries for more than a century, the producers of pharmaceutical, personal care, chemical and food products are increasingly turning to high-shear fluid processing when highly precise processing is required…
Jerry Fireman
Diagnostic Hybrids Inc. manufactures discrete units of mammalian cell cultures and diagnostic reagents—such as antibodies—that are used to grow, isolate and type viruses. The company faced complex information-management challenges because of its many different product offerings, complex…
According to the Institute of Medicine, there are approximately 100,000 people per year killed in the Unites States because of medical errors. There are 100,000 families in despair because they have lost a loved one too soon. This also means that 100,000 medical professionals are losing…