FDA Compliance Features

Environmental Quality Corner with Ken Appel's picture
Environmental Quality Corner with Ken Appel
Ken Appel is the manager of regulated industries for Veriteq. T he U.S. Food and Drug Administration (FDA) and its European Union counterparts recently agreed to cooperate on pharmaceutical...
Thomas R. Cutler's picture
Thomas R. Cutler
Food safety standards are becoming increasingly stringent. Although government legislation has long been implemented, your customers may be driving an even higher standard of food safety through the...
The QA Pharm's picture
The QA Pharm
My definition of “specification” is rather simple: It’s a promise. Just like any other promise, you’d better be sincere when you make it and be able to keep it. Failure to keep a promise brings...
The QA Pharm's picture
The QA Pharm
We hear much about the importance of listening to customers and meeting their needs. Lean Six Sigma devotees say that metrics from the customer’s vantage point are at the center of their philosophy...
Sal Lucido's picture
Sal Lucido
Figure 1: Closed-loop process for managing regulatory compliance In Part I, Part II, and Part III of this compliance series, I have described the benefits of using a closed-...
The QA Pharm's picture
The QA Pharm
One of the regulatory responsibilities of the quality control department is the release decision for drug batches into the market. When I was first given that responsibility early in my quality...
Environmental Quality Corner with Ken Appel's picture
Environmental Quality Corner with Ken Appel
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...
Sal Lucido's picture
Sal Lucido
In Part I and Part II of this series we discussed the benefits of using a closed-loop process for managing regulatory compliance called the “circle of compliance,” pictured in figure 1. I also...
Oriel STAT A MATRIX's picture
Oriel STAT A MATRIX
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...
Environmental Quality Corner with Ken Appel's picture
Environmental Quality Corner with Ken Appel
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. citizens who care about any issue and...
Gene Rider's picture
Gene Rider
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....
Sal Lucido's picture
Sal Lucido
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,...
Anonymous's picture
Michael Leary
In the classic Aesop fable, “The Fox and the Grapes,” a fox desires some grapes hanging high overhead. When he is unable to come up with a way to reach them, he convinces himself that the grapes are...
Environmental Quality Corner with Ken Appel's picture
Environmental Quality Corner with Ken Appel
At the time of this writing, inspectors from the Food and Drug Administration (FDA) are at work monitoring seafood safety in areas affected by the oil spill in the Gulf of Mexico. Finger-pointing...
The Un-Comfort Zone With Robert Wilson's picture
The Un-Comfort Zone With Robert Wilson
With the morning mist still on the Hudson River and the sun just kissing the cliff tops of the New Jersey Palisade, Aaron Burr, vice president of the United States, shot and killed former Secretary...
Oriel STAT A MATRIX's picture
Oriel STAT A MATRIX
In recent years, there have been published reports of an increase in Food and Drug Administration (FDA) inspectional observations associated with training deficiencies. Specifically, these...
Environmental Quality Corner with Ken Appel's picture
Environmental Quality Corner with Ken Appel
Having exhibited at INTERPHEX for many years, Veriteq, a provider of environmental monitoring and validation solutions, has made many connections with leading pharmaceutical and biotech companies. ...
Anonymous's picture
Jennifer Patterson Lorenzetti
Where does the U.S. Food and Drug Administration (FDA) stand on good manufacturing practices (GMP), the set of regulations that govern manufacture and testing of medical devices and other medical...
Anonymous's picture
TWI Institute
(TWI Institute: Liverpool, NY) -- Training within industry is needed more now, in this down economy, than ever before. It was in a time of crisis that the Training Within Industry (TWI) Service ...
Oriel STAT A MATRIX's picture
Oriel STAT A MATRIX
After years of focusing on the pharmaceutical industry and establishing better controls for reviewing the safety and efficacy of pharmaceutical products prior to approval, the Food and Drug...