Top Adding - Computers and Technology

I just read an article about certification and it blew me away. It was pretty good! I was impressed BUT.

Here is the fact. Corporate America does not care about certification at least for networks or computers. It cares when it comes to SOX or CPAs and even project ma

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

nager certification.

But a network? Or computer certification? Give me a break.

I do not mean to rain on your Christmas Parade but this is true. Certification means zero in the corporate world. Now, I have zero facts or proof to prove my theory. But that is enough.

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

Think about these questions from a Managers perspective.

1. How will it benefit the bottom line?
2. Will we see a profit from it?
3. Will this make my training budget go out the ceiling?
4. How long will the certified person stay with the company?
5.

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

Is the person being certified qualified?
6. Do we as manager really understand the certification process?
(there are more but I could not think of them this late at night)

Question 1: Certification will do nothing to boost the bottom line. Period. Sorry but t

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

hat is the honest to gosh truth.

Question 2: See a Profit? Please. Certification is an expensive use of training dollars. I can think of better uses for that money than sending it to Brother Bill (a.k.a. Microsoft).

Question 3: Training Budget...hahahahaha.... When

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

things get tough you will see this line item get the axe first. It always does. Too much history supporting this.

Question 4: Good question. Management will place restrictions on an individual for getting this training like "You will have to stay with the company for

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

5 years if we do this for you!". And then they don't give you decent raises during that time period; that's classic - I hope you saw that coming friend.

Question 5: This is a good one. This company paid to get the computer geek certified and guess what? He was an idi

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

ot. Could not tie his shoes or take regular bathes. In fact, if he came to work on your computer he would sit there and change all of the setting on the computer back to their default settings. The REAL support people never had a chance to get that training because they

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

could not leave their job due to their importance level but he could go! WOW. True story.

Question 6: ABSOLUTELY NOT! For you managers or even Senior Managers reading this just GOTO to the MANAGERS START READING HERE AGAIN section and don't finish this questio

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

n. I would venture to say that these kinds of leaders need certifying themselves to see if they are qualified to lead as managers. Just like we all know there are people in this world that need to be tested to become parents.

Now I'm not saying all managers fit this mol

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

but the majority do. In fact the ignorance of this group makes the good ones look bad. I had this Sr. Manager once that promised me that certification would be approved for all of my staff. I was to prepare my budget and submit it. At the first budget meeting at that

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

senior level our training was the first area that got the axe; all 100 percent of it. The excuse, well we are smart people we can figure this tech stuff out without the classes. After all, we are the geeks.

I even had another boss that believed training was worthless be

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

cause of the same reason. He felt that I was smarter than what the class would teach me and he felt that on the job training was of greater importance. Needless to say, my salary was cut due to his ignorance of computers and networks.

MANAGERS START READING HERE AGAI

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

N.
So why the downer spirit on Certification?

It is very similar to the nursing field. They have certification but Microsoft does not run it or control it. CPAs do not have to worry about some other for-profit organization telling them what to test and how to t

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

est.

But you see, Microsoft does. In their infinite wisdom, they think they know more about what is needed for certification than us geeks. From a technical perspective maybe they do but certainly not from an application standpoint.

What if Consumer Reports was run by

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

General Motors or Ford or even Pepsi? It would not be done right.

You see certification needs to be INDEPENDENT. Why? Have you not been reading this article? Microsoft needs to let go and this industry needs to pick up the slack before the techno idiots take it from u

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

s.

If you truly want to get certified then I say do it. But be smart in obtaining this cert. Get something that will kick butt.

A couple come to mind; CISSP, GIAC and Cisco has a Professional grade as well.

These are well regarded as the best and you will rake in the

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

dollars with these tags on your name.

As far as MCSE is concerned or whatever Microsoft is calling it; I will pass on them. I have been burned too many times by management trying to get it and I have had to fix too many screws-up’s caused by MCSE certified professionals.

.

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

Remember, we as true professional should control the industry not some large corporation with zero experience in a true working environment. My last point I will make is this. Too many times in the training class the instructor will say "You will need to know this answ

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

er for the test! But in the real world we do not do this technique this way. Microsoft wants corporate America to do this their way."

So now you know where my Bah Humbug is directed. Towards a Microsoft controlled certification process. Our industry needs INDEPENDENCE

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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Whether you are about to graduate from college, or want to change jobs at a later point in life, career planning is a very important aspect of the process.

In these times of corporate speed, agility, and web-years, why do so many companies insist on creating strategic plans with 5-10 year planning horizons?

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