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    Everyone has heard of the streams of illegal aliens that are crossing into America. We know that they’re coming here to better their lives, to find work.

    But, what kind of work are they finding? Are they becoming police officers? Firemen? Doctors? Lawyers?

    No. In many cases they are ta
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    king low paying jobs in service related industries like lawn maintenance, painting, restaurants, and… janitorial.

    Now, you might think that having an illegal alien cleaning your building is a big thing. But after reading this article, you may change your opinion.

    Question: Who has total ac
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ess to your facility, even in areas where certain employees aren’t allowed?

    Answer: The Janitor!

    Question: Who can freely come and go at all hours of the night, usually without being questioned?

    Answer: The Janitor!

    Question: Who removes small and large items from your facility, sometime
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    s taking them home?

    Answer: The Janitor!

    Question: Who has 10-12 hours a day to ramble through your company’s and employee’s property, and could find confidential information that could be sold on the Internet?

    Answer: The Janitor!

    You see, the janitor is expected to come to work after ho
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    rs. They are expected to remove trash from the building! They’re expected to spend extra time in the building, making sure they’ve done a quality job.

    But, they’re not expected to steal, surf the Internet, ramble through company records or the like. However, that’s exactly what happens in
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    many cases?

    Why?

    The reasons are numerous, but a common thread can be traced back to the fact that many janitorial companies have become accustomed to hiring illegal aliens to service their accounts.

    The reason they give is because of the highly competitive custodial market that we’re faci
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    ng. After all, most cities do not require a license to start a cleaning company. Most business could care less about experience; they just want the lowest bidder. Most employees don’t mind getting paid in cash, ‘under the table’. And, most owners of cleaning companies will accommodate al
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    of the above needs, as long as they can make a profit!

    However, what’s the threat a business owner is faced with, when they hire a company that employs illegal workers?

    Consider the following: · That business is faced with the possibility that the illegal worker may be planning to return
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    to their native land, and isn’t planning on going empty handed. That worker could leave with a mop bucker or vacuum, but in many cases, they choose your laptop computer or TV. · Illegal workers have been known to attempt to extort money from America’s via the Internet or by phone, from thei
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    home country. After leaving the state, it is discovered that medical records, financial records, corporate records, etc. have been compromised. Whether it be an employee’s Social Security number or a customers credit card number, once this information is outside of the United States, ther
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    is little that a business owner can do. Once published or sold on the Internet, the expense and damage done can be unimaginable. · It’s been reported that false workers compensation claims have been filed against business owners who had illegal aliens in their building. This may be due in
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    part to the how the cleaning company, who actually hired the worker, is structured. If an employer has hired illegal aliens to clean your building, it is a pretty good guess that they are doing other things that are illegal, too. Like operating without adequate insurance. (Did you know t
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    at some companies will write a check for their insurance, knowing that their check will bounce? Why? So that they can give you a certificate of insurance, ‘proving’ they’re insured. Once their check bounces, the policy will be cancelled immediately. However, you still believe that they’re
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    covered, when they and their employees are not!) Since their employer doesn’t have insurance to file against, guess whose next on the list? The business owner! Of course, you can sue the cleaning company, but remember, they’re not the most honest individuals in the first place. After a
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    l, they knowingly gave the keys to your building to an illegal alien. Good luck on collecting a dime!

    These are just some of the risk associated with allowing an illegal worker to clean your building. But, what is a business owner to do?

    First, ask for their General Liability and Workers
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    ompensation Insurance policy carriers list you as a Certificate Holder. This tells the Insurance Company that one of their customers (the cleaning company) is cleaning your building, and if for any reason their policy lapses, you are to be notified immediately. Also, if there is a claim aga
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    inst the cleaning company, you will be first in line to collect.

    Also, you could ask the cleaning company to supply a Fidelity Bond. A Fidelity Bond is insurance against fraudulent acts that cause a lost by individuals. Usually it is put in place to protect a business owner against dishone
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    t acts (theft, damages, etc.) by their own employees. However, a reputable cleaning company should be able to secure one as well.

    Finally, a business owner should always stay in close communication with the owner or their representative of the cleaning company. You should require that all
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    personnel changes must be submitted in writing before said changes are implemented. Also, make sure that your building and office keys are marked ‘Do Not Duplicate’ and individually numbered and recorded. That way when a change in cleaning personnel takes place you will be better able to mo
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    itor any changes, and address potential problems before they become ‘front page’ news.

    Bottom line, as a business owner, you have to be proactive to protect the physical and intellectual property of your company, your employees and your customers.

    D. Brownlee http://www.BreakTheCycleOKC.co


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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