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All Articles Written By: Norm Howe

1.   Where Will FDA Target Next? What IVD Manufacturers Should Know Before Their Next FDA Audit by Norm Howe
    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.
    Distributed: 2011-09-12 10:15:00 | Word Count: 706 | Page Views: 537 | Votes: 0 | Rating: 0.00
2.   How to Evaluate the Quality of a Dietary Supplement by Norm Howe
    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?"
    Distributed: 2010-11-02 12:15:00 | Word Count: 751 | Page Views: 5410 | Votes: 7 | Rating: 0.57
3.   Off-Label Use of Medical Devices by Norm Howe
    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.
    Distributed: 2010-06-22 11:00:00 | Word Count: 621 | Page Views: 6063 | Votes: 3 | Rating: 1.67
4.   A New Paradigm to Address the High Cost of Vendor Qualification by Norm Howe
    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...
    Distributed: 2010-01-12 13:00:00 | Word Count: 1160 | Page Views: 4495 | Votes: 6 | Rating: 1.17
5.   FDA's New Process Validation Guidance Recommends Team Approach by Norm Howe
    The November 2008 FDA draft guidance for process validation says "We recommend an integrated team approach to process validation that includes expertise from a variety of disciplines..."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?
    Distributed: 2009-03-10 11:48:00 | Word Count: 666 | Page Views: 5306 | Votes: 9 | Rating: 0.67
6.   The Myth of the Generic SOP by Norm Howe
    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.
    Distributed: 2009-03-03 12:48:00 | Word Count: 687 | Page Views: 4879 | Votes: 8 | Rating: 2.00
7.   The Evolution of Process Validation by Norm Howe
    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?
    Distributed: 2009-01-27 12:48:00 | Word Count: 471 | Page Views: 6666 | Votes: 15 | Rating: 1.53
8.   FDA's New Process Validation Guidance Recommends Team Approach by Norm Howe
    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?
    Distributed: 2009-01-21 12:36:00 | Word Count: 665 | Page Views: 6491 | Votes: 9 | Rating: 2.78
9.   Proposed FDA Compliance Guide to Assist Small Dietary Supplement Manufacturers by Norm Howe
    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.
    Distributed: 2009-01-05 11:00:00 | Word Count: 440 | Page Views: 4485 | Votes: 8 | Rating: 1.38
10.   Dietary Supplements Must Be Tested by Scientifically Valid Methods by Norm Howe
    Are you a Dietary Supplement manufacturer trying to figure out what FDA means by "Scientifically Valid Method"? Here are some hints.
    Distributed: 2008-09-03 12:24:00 | Word Count: 424 | Page Views: 5553 | Votes: 8 | Rating: 0.88
11.   FDA Cracks Down on Fake Cures by Norm Howe
    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.
    Distributed: 2008-08-14 11:36:00 | Word Count: 406 | Page Views: 5664 | Votes: 17 | Rating: 1.76
12.   Relief For Latex Allergy Sufferers As FDA Clears New Medical Glove by Norm Howe
    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.
    Distributed: 2008-07-29 11:00:00 | Word Count: 460 | Page Views: 4527 | Votes: 10 | Rating: 2.60
13.   Quality by Design Streamlines Pharmaceutical Manufacturing by Norm Howe
    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.
    Distributed: 2008-06-24 11:12:00 | Word Count: 453 | Page Views: 5754 | Votes: 7 | Rating: 2.14
14.   Five Ways to Alienate Your Employees: A Manager's Guide To Investigating Errors by Norm Howe
    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.
    Distributed: 2008-04-23 10:48:00 | Word Count: 787 | Page Views: 6041 | Votes: 10 | Rating: 0.70
15.   Options for Container and Closure Systems Sterility Testing by Norm Howe
    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.
    Distributed: 2008-04-01 11:48:00 | Word Count: 656 | Page Views: 7397 | Votes: 5 | Rating: 1.00
16.   New Dietary Supplement Regulations: What You Need to Know by Norm Howe
    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.
    Distributed: 2008-03-13 11:12:00 | Word Count: 606 | Page Views: 4431 | Votes: 14 | Rating: 2.29
17.   Security Tools for Food and Cosmetics Help Protect Consumers by Norm Howe
    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.
    Distributed: 2008-02-20 10:36:00 | Word Count: 414 | Page Views: 4540 | Votes: 7 | Rating: 2.00
18.   Product Mislabeling Makes Recalls Likely by Norm Howe
    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.
    Distributed: 2008-01-07 11:00:00 | Word Count: 612 | Page Views: 8002 | Votes: 11 | Rating: 1.55
19.   Medical Device Recall Hurts Everyone by Norm Howe
    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.
    Distributed: 2007-12-11 10:24:00 | Word Count: 581 | Page Views: 5086 | Votes: 10 | Rating: 2.50
20.   How to Get Your Project Approved by Norm Howe
    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?
    Distributed: 2007-12-05 11:24:00 | Word Count: 1298 | Page Views: 4144 | Votes: 7 | Rating: 1.71

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