Grant Ramaley
Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent. A recent report published by...
Patrick Stone
The Food and Drug Administration’s (FDA) “Food Police” will be in full force to secure budget funds for food safety initiatives for FY 2014 as mandated by Congress. More than half of the operating...
Mike Roberts
My colleagues and I at LNS Research have spoken to numerous companies during the past several years that have done an admirable job of building compliance into production processes. However, there...
Margaret A. Hamburg
There are many good reasons to go to Arkansas in September: to visit Little Rock, America’s No. 1 most livable city; or attend the annual Eureka Springs Antique Automobile Festival, to name two....
Paul Naysmith
Arecent call with an old colleague from Europe got me wondering about a question that few are conscious of: Who is the customer of your quality document? Oh boy, did we have an interesting discussion...
Dennis Payton
Given the Food and Drug Administration’s (FDA) increased findings for companies that must comply to CFR 21 Part 820—“Quality system,” it’s curious that the oversight body has not offered much...
Stericycle Inc.
According to the quarterly ExpertRECALL Index, 48 percent of all medical device recalls reported during the second quarter of 2013 had both U.S. and international components. In addition, the...
Bakul Patel
Many medical devices today perform at least one function by using wireless technology to support health care delivery. In telemedicine, for example, a wireless device can enable real-time...
Bakul Patel
For medical devices, the term “interoperability” refers to the ability of various devices to interact, and for electronic health record systems to talk to each other using a common vocabulary. It...
Margaret A. Hamburg
It’s a small world. Every day, there’s a good chance that some of the food you’re eating came from another country. Fifteen percent of the food we eat, including nearly 50 percent of the fresh...
The QA Pharm
Editor's note: This is the first in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance...
David S. Buckles
Disagreements are inevitable in science, medicine—and even life. As part of a regulatory agency committed to public health, the Food and Drug Administration’s (FDA) medical devices center...
Michael Causey
In a new 47-page guidance the Food and Drug Administration (FDA) appears to be doing its best to cover the waterfront for medical device manufacturers who need to better understand the complex...
Kimberly Egan
What do China, Maine, Connecticut, Chipotle, and Whole Foods have in common? They all think you have a right to know whether the food you are eating contains any genetically modified organisms,...
Michael Causey
The Internet giveth and the Internet taketh away. For years, we’ve been hearing about the benefits online tools will bring to the medical industry, especially at hospitals and physicians’ offices...
John Roth
In an earlier article, I explained how the Food and Drug Administration’s (FDA) Office of Criminal Investigation (OCI) works when a small portion of the industry fails to adequately respond to...
Michael Causey
The shell game called the federal budget added another nut recently as media reports revealed that during the last 20 years, approximately $1 billion in fees paid by patent applicants has been...
James Andrews
T
ake a moment to consider some of the foods we find at the supermarket: eggs, tomatoes, coffee — maybe even chocolate chip peppermint brownie ice cream. Now, try to imagine all the steps and...
Michael Causey
The latest batch of Food and Drug Administration (FDA) inspection letters noting objectionable conditions, aka 483s, has a decidedly international flair: Italy, Japan, and Canada had the...
Quality Digest
On March 28, 2013, the world lost a person whom many consider to be a major contributor to the world of industrial statistics: George E. P. Box. Relatively unknown outside the world of statistics,...
