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    I’ll never forget the warmth of the desert sun the day that I was told I did it all wrong. No training, but high expectations in assuming that I knew the difference between oil and water based paints.

    Yes, when I was about 7 years old, my older sister
    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
    and her husband took me for a weekend trip to the desert house of my brother-in-law’s father. I was excited to be helpful on the warm Saturday morning. The Father assigned me the task of opening up several partially used cans of paint and combining li
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    e colors in single cans.

    When I finished the chore, I was quite pleased with myself. The Father checked my work and became angry and agitated. He realized that I had mixed together the water based and oil based white paints. I did not understand the d
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ifference in paint bases. He proceeded to tell me that I was a bad boy and could use a spanking.

    You might be thinking, “Gosh—the Father should have instructed the 7 year old a little bit better as to the expectations of the job and offered a degree o
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    training.” I agree with you whole-heartedly. Funny thing is, adults do the same to other adults quite frequently in the work place.

    In most businesses, training and trust (T&T) makes the difference between high-performance employees and just average
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    mployees. This is also evident in seemingly productive environments. Even if your business had a 20% increase last year, do you know for a fact that your increase shouldn’t have been 25%?

    Developing a culture of trust must be done on a solid foundatio
    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
    n of comprehensive and effective employee training. In all too many companies, I’ve seen the culture of employee training akin to that of throwing a child in the pool and expecting that child to swim to the safety of the pool’s edge all by themselves.
    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
    ou know what I mean, hiring an employee and giving them just enough knowledge to bumble along and figuring that in time, they will catch on. In a recent interview, the folks at Dell Computers even admitted that that’s how they did it in their early day
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    .

    Why not take the time and train your employees well from the start? Is it because you do not have a methodical system for training that you can replicate accurately? This would be my first guess. Is it because you are just too darn busy? Is it becau
    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
    se you never gave it much thought? Whatever the reason, understand that when employees are not trained well, there is the tendency among supervisory personnel to frequently check up and second guess the work of those under their charge.

    This exemplifi
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    s mistrust. When a supervisory or management person goes behind the employee, especially a veteran, and either supplements or changes the work or a completed task of an employee, what they are really saying to the employee, and saying it loud and clear
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    is, “I don’t trust you.” If by word or deed, you say too frequently to an employee, “I don’t trust you.” The employee will eventually become demoralized and abandon any emotional ownership that they might have in the success of the enterprise. The resu
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    lt will be just another mediocre employee, that management considers easily replaceable.

    Supervisors then find themselves babysitting employees rather than seizing the opportunities for productivity increases and or resource savings. It all spirals in
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    o a culture of mistrust between employees and supervisors and management. The result being lost productivity, even if there might be productivity increases—just not the level of increases possible.

    The solution is to develop a culture of trust upon th
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    foundation of comprehensive and effective training. Answer for yourself a few questions about how your organization operates:

    1. Can your training system be replicated from supervisor to supervisor and from department to department?

    2. Is your train
    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
    ing system in writing?

    3. Do you have metrics for measuring the effectiveness of the individuals that train new employees?

    4. Do you have a periodic (one week, then one month, then six months) follow up system or mechanism for new employees to offer
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    eedback on how well they feel they were trained to do the required job?

    5. Do you have a bi-annual system for employees to rate their supervisors?

    6. Are your supervisors aware that when they do things, change things, and/ or supplement things behind
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    the backs of your employees, they are telling your employees, by deed, that they don’t trust your employees?

    T&T is the answer! Training well, and then trusting your employees is the key to high productivity. That does not mean you cannot check up on
    .

    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
    employees, by all means it is prudent to do that. But don’t do it behind their backs. If an issue is uncovered, go directly to the employee and re-train and re-educate. This will develop a culture of trust. And, in a trusting workplace, employees have
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    greater emotional ownership in the success of the enterprise.

    To access helpful additional information from Ed Rigsbee at no charge, please visit www.rigsbee.com/downloadaccess.htm


    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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