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Where Will FDA Target Next? What IVD Manufacturers Should Know Before Their Next FDA Audit by Norm Howe |
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Medical device manufacturers are always interested in knowing
what FDA's next area of focus will be. Well, if you're an In
Vitro Diagnostic manufacturer you might review your measurement
systems. |
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Distributed: 2011-09-12 10:15:00 |
Word Count: 706 |
Page Views: 537 |
Votes: 0 |
Rating: 0.00 |
| 2. |
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How to Evaluate the Quality of a Dietary Supplement by Norm Howe |
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So, you've found a Dietary Supplement that exactly fits
your special need. The information on the supplier's
website appears to be consistent with everything that
you've read and heard, and now you're ready to buy. But
there are questions on your mind. "What is the quality of
this product that I'm buying?" you ask. "Can I really
trust this supplier?" |
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Distributed: 2010-11-02 12:15:00 |
Word Count: 751 |
Page Views: 5410 |
Votes: 7 |
Rating: 0.57 |
| 3. |
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Off-Label Use of Medical Devices by Norm Howe |
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How can a medical practitioner decide whether a medical device
that they want to use for one of their patients is legal and
approved by the Food and Drug Administration? When a patient
comes into a physician's office the patient is looking for the
best, most modern care they can get. And a physician certainly
wants the same thing. |
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Distributed: 2010-06-22 11:00:00 |
Word Count: 621 |
Page Views: 6063 |
Votes: 3 |
Rating: 1.67 |
| 4. |
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A New Paradigm to Address the High Cost of Vendor Qualification by Norm Howe |
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The assumption today is that a BETTER audit means a LONGER
audit. There has to be another way. What's needed is a new
paradigm for vendor qualification; a tool that can drill
deeply into the vendor's operation at low cost; something
that can provide a more lasting measure of the vendor's
performance than simply an audit... |
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Distributed: 2010-01-12 13:00:00 |
Word Count: 1160 |
Page Views: 4495 |
Votes: 6 |
Rating: 1.17 |
| 5. |
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FDA's New Process Validation Guidance Recommends Team Approach by Norm Howe |
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The November 2008 FDA draft guidance for process validation says
"We recommend an integrated team approach to process validation
that includes expertise from a variety of disciplines..." But
when different people from different backgrounds work together,
disagreements can stall your team. How do you get your project
back on track? |
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Distributed: 2009-03-10 11:48:00 |
Word Count: 666 |
Page Views: 5306 |
Votes: 9 |
Rating: 0.67 |
| 6. |
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The Myth of the Generic SOP by Norm Howe |
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What do you do when your boss tells you to write an SOP? Run and
hide? Tell her how long it will really take to write one that's
any good? If you choose the latter option, be prepared for this
"helpful suggestion": "Why don't you just download a generic
SOP from the internet?" You would have been better off taking
the former option. Here's why. |
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Distributed: 2009-03-03 12:48:00 |
Word Count: 687 |
Page Views: 4879 |
Votes: 8 |
Rating: 2.00 |
| 7. |
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The Evolution of Process Validation by Norm Howe |
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In November 2008, the U.S. Food and Drug Administration (FDA)
published draft guidance on process validation. Entitled Process
Validation: General Principles and Practices, this draft guidance
replaces the previous guidance issued in 1987. What does this
mean to you? |
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Distributed: 2009-01-27 12:48:00 |
Word Count: 471 |
Page Views: 6666 |
Votes: 15 |
Rating: 1.53 |
| 8. |
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FDA's New Process Validation Guidance Recommends Team Approach by Norm Howe |
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The November 2008 FDA draft guidance for process validation says
"We recommend an integrated team approach to process validation
that includes expertise from a variety of disciplines..." But
when different people from different backgrounds work together,
disagreements can stall your team. How do you get your project
back on track? |
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Distributed: 2009-01-21 12:36:00 |
Word Count: 665 |
Page Views: 6491 |
Votes: 9 |
Rating: 2.78 |
| 9. |
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Proposed FDA Compliance Guide to Assist Small Dietary Supplement Manufacturers by Norm Howe |
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How do small Dietary Supplement manufacturers comply with the new
Dietary Supplement GMPs? The U.S. Food and Drug Administration
(FDA) announced plans to publish a compliance guide that will
provide assistance to small dietary supplement manufacturers. |
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Distributed: 2009-01-05 11:00:00 |
Word Count: 440 |
Page Views: 4485 |
Votes: 8 |
Rating: 1.38 |
| 10. |
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Dietary Supplements Must Be Tested by Scientifically Valid Methods by Norm Howe |
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Are you a Dietary Supplement manufacturer trying to figure out
what FDA means by "Scientifically Valid Method"? Here are some
hints. |
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Distributed: 2008-09-03 12:24:00 |
Word Count: 424 |
Page Views: 5553 |
Votes: 8 |
Rating: 0.88 |
| 11. |
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FDA Cracks Down on Fake Cures by Norm Howe |
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In an effort to crack down on charlatans who prey on the sick,
the U.S. Food and Drug Administration (FDA) recently issued
warning letters to 23 U.S. companies and two foreign individuals
marketing a wide range of products that fraudulently claim to
prevent and cure cancer. |
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Distributed: 2008-08-14 11:36:00 |
Word Count: 406 |
Page Views: 5664 |
Votes: 17 |
Rating: 1.76 |
| 12. |
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Relief For Latex Allergy Sufferers As FDA Clears New Medical Glove by Norm Howe |
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Most allergies are easy to cope with by simply avoiding the
trigger. Sometimes that's easier said than done, such as in the
case of a latex allergy. Estimates vary, but anywhere from 3
percent to 22 percent of all health care workers are sensitized
to traditional latex. FDA recently cleared for marketing the
first device made from a new form of natural rubber latex called
guayule latex. |
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Distributed: 2008-07-29 11:00:00 |
Word Count: 460 |
Page Views: 4527 |
Votes: 10 |
Rating: 2.60 |
| 13. |
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Quality by Design Streamlines Pharmaceutical Manufacturing by Norm Howe |
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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. |
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Distributed: 2008-06-24 11:12:00 |
Word Count: 453 |
Page Views: 5754 |
Votes: 7 |
Rating: 2.14 |
| 14. |
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Five Ways to Alienate Your Employees: A Manager's Guide To Investigating Errors by Norm Howe |
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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. |
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Distributed: 2008-04-23 10:48:00 |
Word Count: 787 |
Page Views: 6041 |
Votes: 10 |
Rating: 0.70 |
| 15. |
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Options for Container and Closure Systems Sterility Testing by Norm Howe |
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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. |
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Distributed: 2008-04-01 11:48:00 |
Word Count: 656 |
Page Views: 7397 |
Votes: 5 |
Rating: 1.00 |
| 16. |
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New Dietary Supplement Regulations: What You Need to Know by Norm Howe |
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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. |
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Distributed: 2008-03-13 11:12:00 |
Word Count: 606 |
Page Views: 4431 |
Votes: 14 |
Rating: 2.29 |
| 17. |
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Security Tools for Food and Cosmetics Help Protect Consumers by Norm Howe |
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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. |
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Distributed: 2008-02-20 10:36:00 |
Word Count: 414 |
Page Views: 4540 |
Votes: 7 |
Rating: 2.00 |
| 18. |
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Product Mislabeling Makes Recalls Likely by Norm Howe |
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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. |
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Distributed: 2008-01-07 11:00:00 |
Word Count: 612 |
Page Views: 8002 |
Votes: 11 |
Rating: 1.55 |
| 19. |
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Medical Device Recall Hurts Everyone by Norm Howe |
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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. |
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Distributed: 2007-12-11 10:24:00 |
Word Count: 581 |
Page Views: 5086 |
Votes: 10 |
Rating: 2.50 |
| 20. |
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How to Get Your Project Approved by Norm Howe |
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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? |
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Distributed: 2007-12-05 11:24:00 |
Word Count: 1298 |
Page Views: 4144 |
Votes: 7 |
Rating: 1.71 |
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