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DID YOU KNOW...

That problems with printed and electronic ?rogue? documents?which wind up being exchanged via email, or shuffled around the office or shop floor? can be eliminated?
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Especially for Pharmaceuticals

Speed-to-market objectives in pharmaceutical/biotech companies are being redefined in today?s more competitive and stricter regulatory environment.
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Especially for Pharmaceuticals


Especially for Medical Devices

GxP Lifeline recently interviewed Janet Woodcock, FDA's Deputy Commissioner for Scientific and Medical Programs and Chief Medical Officer, about FDA?s Critical Path Initiative. In a recent FDA interview, she explains the Critical Path, FDA?s effort to help modernize the scientific process through which medical products are developed, evaluated and manufactured.
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Especially for Blood / Biologics

The U.S. is a major supplier of plasma products; it provides 60 percent of the world’s needs for plasma, both recovered and source. As a major player in the European plasma market, U.S. blood centers must undergo assessment by the European Union (EU). How should a U.S. blood center prepare for a European inspection?
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Adopting Technology in the Life Science Industry: Why Is It Taking So Long?
By
Curt Porritt

In 1943, Thomas Watson, the chairman of IBM, made the following now infamous statement about the potential impact of technology, “I think there is a world market for maybe five computers.”1 It would be hard to express in words how shortsighted his view was.

Amazingly, this misunderstanding of the potential advantages of technology still exists in the mindsets of many otherwise intelligent and successful people. For example, it was just a few years ago that a successful vice president of sales asked me, “Even if I had a computer and access to the Internet, what would I do with it?” To me this was like asking, “If I had a car, where could I go with it?” Yet, a few months ago, when this same VP of Sales’ laptop crashed, you’d have thought he had been paralyzed from the neck down. He simply couldn’t function. Every aspect of his life from social activities to his job came to a screeching halt.

It’s a well-known fact that pharmaceutical and medical device companies are slow in adopting some of the most basic technologies. Clearly, this attitude is hurting their productivity, quality, and time to market. However, what’s worse is that a basic misunderstanding of the potential advantages of electronic solutions still pervades these industries, especially among small- to mid-sized companies. All you have to do to substantiate this claim is attend the lectures at various life science-oriented regulatory or quality control conferences. When discussing fundamental issues, such as process management, compliance, document control, training, submissions, etc., these “experts” rarely discuss using the latest technologies to solve some of their most basic problems. I even heard one experienced consultant say, “The use of massive amounts of paper will never be replaced by electronic formats in this industry.” This sounds amazingly similar to the statement made by Thomas Watson back in 1943.

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How Soon Can You Get Me That Six-Year-Old Data?
By
Daniel R. Matlis

On January 10, 2007, The Food and Drug Administration (FDA) notified pharmaceutical companies  of its recommendation that they reevaluate, confirm or repeat analytic studies used in the approval of some drug products.
 
The action was a result of FDA inspections at two MDS Pharma Services (MDS Pharma) Canadian facilities that raised questions about the validity and accuracy of test results from studies conducted by MDS Pharma from 2000 through 2004.

MDS Pharma performed pharmacokinetic testing services for a number of pharmaceutical companies. These studies are used to measure the level of drug in a patient’s blood. The results of pharmacokinetic studies are required by FDA for the approval of a New Drug Application (NDA).

As a result of these findings, the Agency sent over 1,000 letters to sponsors of pharmaceutical products for both brand-name and generic drugs.

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Upcoming Events

Check out conferences, trade shows, and other events for life science professionals.

MD&M Minneapolis Complimentary Event Coupon
(Oct. 17-18, 2007)

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Editorial Staff

Know the difference between IDE and IND? Between a 483 and a Warning Letter? How about GMP versus GTP?
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Editorial Staff

We Want Your Feature Articles


GxP Lifeline welcomes articles that are informative, interesting, and useful to life science professionals.
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Editorial Staff

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Publisher: Curt Porritt
Executive Editor: Jason Clegg
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