All Features
Geoff Bilau
Geoff Bilau, senior writer for the International Association for Plumbing and Mechanical Officials (IAPMO) Group, was awarded first place for his paper by the American National Standards Institute (ANSI) for describing the importants of quality standards and accreditation.
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James Odom
Charles Kettering, the famous inventor, once said: “A problem well stated is a problem half solved.” This implies that a good portion of problem solving should be devoted to a thorough understanding of what’s going on before any corrective action steps are taken.
In many cases, too much time is…
Sandford Liebesman
I've been auditing to ISO 9001 since 1992. A part of my auditing philosophy has been to add value to the audited organizations by suggesting opportunities for improvement. Following, I will describe the most effective “value adds.”
Continual improvement
Look at ISO 9001:2000 subclause 8.5.1--"…
Tamar June
The Food and Drug Administration (FDA) has had many challenges and setbacks in the past few years. From budget cuts, to high-level departures, the agency has also faced fury from lawmakers on Capitol Hill over high-profile device, drug, and food recalls.
Off the record, current, and former…
Lysosomal storage disorders may not sound as dire as diseases such as cancer or Alzheimer’s, but to the people that suffer from them, life can be a nightmare. In fact, three of the primary disorders in this category—Gaucher’s Disease, Fabry Disease, and Pompe Disease—aren’t only characterized by a…
Richard Strouse
Internal auditing, when effectively implemented, can arguably be considered the most important tool in the quality system tool box. It’s the primary method for continuously monitoring a company's quality management system (QMS). In fact, the feedback from internal auditing is critical to the growth…
George Rodrigues
Liquid delivery is a common laboratory process and this critical function is often overlooked. As a result, routine research and test results can be in error based on a simple misunderstanding or misapplication of liquid delivery instruments. This article focuses on defining and exploring accuracy…
Rory Granros
When regulatory compliance and risk management come to mind, they usually evoke feelings of fear, uncertainty, and doubt as to how well an organization is prepared for government scrutiny or any worst-case business scenario. Questions arise, such as: Have we developed the proper procedures to…
Nancy Fullbright
Alan Kent, president and CEO of Meadows Regional Medical Center in Vidalia, Ga., was a champion for implementing lean principles in the hospital’s emergency department. Photo by Gary Meek Emergency rooms in the United States aren’t known for their…
From an antacid to a new cancer treatment, every drug must be proven safe and effective in controlled clinical trials before the U.S. Food and Drug Administration (FDA) allows it to be sold in the United States.
When federal law first required controlled clinical trials in 1962, most people…
George Rodrigues
Pharmaceutical processes typically take place on the scale of gallons or liters, even tens of thousands of liters. So why would anyone worry about one little microliter? Because in some situations, deviations as small as one microliter can mean the difference between success and failure.
Modern…
James Jardine
The International Organization for Standardization has developed more than 17,000 international standards on numerous subjects. For medical device companies, the most important of these standards is ISO 13485, which provides internationally recognized guidelines pertaining to quality management…
James Jardine
The International Organization for Standardization has developed more than 17,000 international standards on numerous subjects. For medical device companies, the most important of these standards is ISO 13485, which provides internationally recognized guidelines pertaining to quality management…
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…
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…
