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The QA Pharm
People often ask me how best to prepare for a Food and Drug Administration (FDA) inspection when you know that you have problems. My first response is that they have already taken the first step: acknowledging that there are problems. Believe me; that is a huge first step. Just like Alcoholics…
Taran March @ Quality Digest
Pharmaceutical manufacturer Johnson & Johnson, which for decades has enjoyed a trusted reputation for soothing babies and overcoming head colds, is currently facing criminal investigation by the U.S. Food and Drug Administration (FDA). The company’s McNeil Consumer Healthcare unit closed a…
Digital pen technology is an efficient data management solution that offers better operational visibility, enabling manufacturers to react quickly to the production process and respond to issues via immediate data access. Hyla Soft’s FactoryScribe is a lightweight web application built around…
A new year always brings new hope, new plans, and new perspectives. While looking ahead is the most direct route to progress, looking back is essential to understanding the present. After all, the past creates the consequences that will shape the future.
With this in mind, the editors of…
Environmental Quality Corner with Ken Appel
Ken Appel is the manager of regulated industries for Veriteq.
In part 1 of this article, we discussed the pros and cons of various systems for stand-alone monitoring instruments (e.g., chart recorders and data loggers) and wired networks, with and without power over Ethernet (POE). In the…
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 plant inspections to enable stepped-up enforcement of safety guidelines. These agreements will help…
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 Global Food Safety Initiative (GFSI) or Safe Quality Food (SQF) Institute, which require third-…
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 disappointment. Frequent failure leads to distrust. And consciously breaking a promise is nothing less…
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.
Many pharmaceutical companies embed their high view of the professional community and patients…
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-loop process for managing regulatory compliance (illustrated in figure 1).
Readers of this series…
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 assurance (QA) career, it was impressed upon me to not count the cost of the batch when making that…
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 August 2003 Guidance for Industry Part 11, Electronic Records; Electronic Signatures—Scope and…
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 showed how setting up key performance indicators (KPIs) that monitor performance to goals is a good way…
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 by the Global Harmonization Task Force (GHTF) founding members using ISO 13485. Manufacturers must…
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 how our legislative process resolves the problems of our time—no matter what their party affiliation…
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. Consumer Product Safety Commission (CPSC) “small parts” standard, for example, are the result of…
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, or financial services—this is a universal mandate.
As someone who serves customers across many…
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 probably sour and therefore not desirable anyway. “Sour grapes” has become an idiomatic expression…
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 continues and there is now talk on the news of criminal prosecutions. The full economic effect of the…
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 of the Treasury Alexander Hamilton. Political opponents for years, the duelists faced each other…
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 inspectional observations have focused on training related to the quality system requirement that…
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. The Veriteq team attending INTERPHEX 2010, on April 20–22, was struck by two trends in the…
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 products like pharmaceuticals, diagnostics, and food? And what of the universal device identification…
(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 proved its worth more than 60 years ago. Today, leading organizations are turning to training within…
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 Administration (FDA) is now directing its attention to the medical device industry.
On Feb. 18, the FDA…
