GxP Lifeline January 2009 - Your Resource for Life Science Intelligence

January 2009

Video:

MasterControl as a Company-Wide Solution

Feature Article:

Life Science Executives Facing Jail Time?

For Pharmaceuticals and Biotechnology:

FD&C Amendments at Work in the Pharmaceutical Industry

For Medical Device:

Creating and Auditing a Global Quality System



For Blood & Biologics:

A Myriad of Documents - Is There Control?

For Dietary Supplements:

Dietary Supplements Testing

Did You Know?

Did you know that pharmaceutical companies have identified ways to improve compliance and reduce risk by "single-sourcing" their training and performance support?


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Life Science Executives Facing Jail Time?

As corporate corruption, with or without executive intent, increasingly comes to light within the life science sector the FDA is reciprocally given additional power to administrate punitive measures.

Take, for example, the punitive measures doled out to the Purdue Frederick Company: $634.5 million after the defendants pleaded guilty to the intentional misbranding and the illegal promotion of the company's OxyContin drug.


For Pharmaceuticals and Biotechnology: FD&C Amendments at Work in the Pharmaceutical Industry

From 1938 to the present day, additional legislation has been amended to the FD&C Act, creating new ripples within the pharmaceutical sector. Many of these amendments directly influence the pharmaceutical industry on a daily basis.


For Medical Device: Creating and Auditing a Global Quality System

The reason that many firms built their quality systems using 21 CFR 820 is that these requirements are more prescriptive. Additionally, for firms located in the United States, FDA can use a host of regulatory sanctions for noncompliance including criminal prosecution against a company and/or its executive decision makers. An FDA inspection is an evaluative process in which the FDA looks to record discrepancies and, if necessary, take regulatory action.


For Blood & Biologics: A Myriad of Documents - Is There Control?

Document control is an issue for every laboratory. Document control is more than generating good documents; it is the ability to compile, review and evaluate documents that are required to ensure the quality of products and services provided. But how?


For Dietary Supplements: Dietary Supplements Testing

The final FDA Rule on Dietary Supplements does not require manufacturers of dietary supplements to test their products before they are marketed. However, some dietary supplements manufacturers choose to test their products, or to contract out this function to independent laboratories.


Did You Know?

Did you know that pharmaceutical companies have identified ways to improve compliance and reduce risk by "single-sourcing" their training and performance support?



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