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Quality by Design Streamlines Pharmaceutical Manufacturing
The pharmaceutical industry wastes more than $50 billion a year
in manufacturing costs according to findings of a study conducted
jointly by Olin School of Business at Washington University and
McDonough School of Business at Georgetown University. The goal
of the study was to understand how the FDA regulates
pharmaceutical production and how those regulations may be
inhibiting advances in manufacturing. Quality by Design ensures
reduced deficiencies, quicker approvals, and improved interaction
with FDA. It also allows for continuous improvements in products
and manufacturing process, as well as a better understanding of
how APIs and excipients affect manufacturing.
Written by: Norm Howe
Distributed: 2008-06-24
- Word Count: 453 - Viewed: 50 - Votes: 0
http://thePhantomWriters.com/free_content/db/h/streamlines-pharmaceutical-manufacturing.shtml
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Five Ways to Alienate Your Employees: A Manager's Guide To Investigating Errors
Are you a manager with too much time on your hands? Do you go
home at the end of an eight hour day with boring regularity,
leaving a clean desk and a clear conscience? Wouldn't you rather
have NO discretionary time in your life? Here are five sure-fire
tips to create fear in your employees and keep them from ever
participating openly during problem solving discussions.
Written by: Norm Howe
Distributed: 2008-04-23
- Word Count: 787 - Viewed: 83 - Votes: 0
http://thePhantomWriters.com/free_content/db/h/alienate-your-employees.shtml
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Options for Container and Closure Systems Sterility Testing
While sterility testing can be cumbersome and time consuming,
there are FDA-approved options regarding container and closure
system integrity testing. In fact, the Food and Drug
Administration (FDA) recently released a guidance document on
container and closure system integrity testing in lieu of
sterility testing as a component of the Stability Protocol for
Sterile Products. The document offers an alternative approach, if
the approach satisfies the requirements of the applicable
statutes and regulations.
Written by: Norm Howe
Distributed: 2008-04-01
- Word Count: 656 - Viewed: 120 - Votes: 0
http://thePhantomWriters.com/free_content/db/h/sterility-testing.shtml
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New Dietary Supplement Regulations: What You Need to Know
Does your company make Dietary Supplements? The Food and Drug
Administration has published new Current Good Manufacturing
Practices (CGMPs) regulations for dietary supplements. These
regulations will affect any manufacturers of dietary supplements
who sell product in the United States. Here are some highlights
of the new regulations.
Written by: Norm Howe
Distributed: 2008-03-13
- Word Count: 606 - Viewed: 92 - Votes: 1 - Rating: 0.00
http://thePhantomWriters.com/free_content/db/h/new-dietary-supplement-regulations.shtml
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Security Tools for Food and Cosmetics Help Protect Consumers
In 2007, the Food and Drug Administration (FDA) launched
self-assessment tools to minimize the risk of intentional
contamination of food and cosmetics. Examples of measures
addressed by the self-assessment tools include the possibility of
product tampering; identification of security procedures and
responsibilities; and evaluation of response strategies in the
event of product tampering or other intentional contamination.
Written by: Norm Howe
Distributed: 2008-02-20
- Word Count: 414 - Viewed: 110 - Votes: 0
http://thePhantomWriters.com/free_content/db/h/security-tools-for-food-and-cosmetics.shtml
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Product Mislabeling Makes Recalls Likely
What happens when drug or medical device manufacturers mislabel
their products? The Food and Drug Administration (FDA) regularly
monitors labels for false claims and errors, often pulling whole
lots of product for which it finds a problem. Case in point: a
recent nationwide recall of Encore Tablets, a dietary supplement
sold in health food stores, via the internet and by mail order
nationwide and in Canada.
Written by: Norm Howe
Distributed: 2008-01-07
- Word Count: 612 - Viewed: 146 - Votes: 0
http://thePhantomWriters.com/free_content/db/h/product-mislabeling.shtml
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Medical Device Recall Hurts Everyone
What happens when a medical device is produced with a defect? Of
course the health of the consumer is placed in jeopardy. But
what about the manufacturer and the physician? Everyone along
the supply chain gets hurt. How can you reduce your risk? One
of the easiest ways to avoid defects in medical device recalls is
through proper validation of the design and manufacturing
processes for such devices.
Written by: Norm Howe
Distributed: 2007-12-11
- Word Count: 581 - Viewed: 151 - Votes: 0
http://thePhantomWriters.com/free_content/db/h/medical-device-recall.shtml
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How to Get Your Project Approved
What do you do when you have a great idea? You know how to save
your company a ton of money or you've thought of a way to really
improve a product. The problem is that you know that you have a
great idea, but no-one else does. And you can't convert this
idea into reality by yourself. You need resources. You need
money. You feel that you need permission. What do you do?
Written by: Norm Howe
Distributed: 2007-12-05
- Word Count: 1298 - Viewed: 146 - Votes: 0
http://thePhantomWriters.com/free_content/db/h/how-to-project-approved.shtml
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