Advice Pool - Business

Safe Work Place Environment

We are required by OSHA to provide a safe workplace environment for our employee’s. I was at a rather

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

large business lunch last month and the gentleman sitting next to me was sharing with us a sad terrible story about an incident tha

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

Examples of combination products may in

t happened at his expanding manufacturing company. Apparently one of his management staff attempted to date a female line technicia

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

, when the young lady refused his numerous advances she threatened to go to the HR department and lodge a compliant. The line manag

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

er waited for the employee by her car and then forced her back into the plant and viciously beat her then raped her repeatedly.

Of

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

Combination pro

course the suspect was arrested and the victim was sent to the hospital, but this is just the beginning of this tragic story. Now t

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

he victim has filed a lawsuit against the employer and he is facing heavy fines from the OSHA investigators who were alerted by the

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

victim’s family. The CEO looked at us and said “I did everything I could to prevent this I have the best security there is, the fin

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

est electronic devices in my plant why is this incident my fault?” Then he asked me to help and for the last few weeks I have been.

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

I found the suspect manager had been arrested and convicted twice for rape in two different states and he was currently on parole.

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

No one knew. I have been explaining to my new friend that a safe work environment is more than physical security you must conduct

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

Following aspects would a

background checks on all staff not only new hires but the current staff as well not just criminal records but credit, DMV records t

dd to the challenges in developing combination products:

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

e patriot act and all the available sexual predator boards. After all these people give you a signed release so you can check out t

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

heir backgrounds take advantage of it protect your people and your company. His first reaction was to say; “Well isn’t that a bit l

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

ke big brother.” My reply was what you are really asking is isn’t that going to cost me a lot of money.

Probably let’s see the fi

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

nes and lawsuits are coming up on Ten million dollars you do the math. Business in the 22nd century is not like doing business ever

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

Professional from academic institutions, pharmaceutical industries, health care indust

was. Let’s talk about the big brother issue, we check public record information we don’t slink around at night in the dark corners

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

compiling secret dossiers on folks. We have the tools we have the technology don’t fear them embrace them. Don’t just initiate a s

.

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

reening program to placate your liability insurance, do it for your people. Even a simple background check would have caught this m

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

Companies that provide selfless information through particip

onster before he traumatized this poor girl who has to live with this the rest of her life. Do the right thing. Protect your people

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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At your next business event, trade show, seminar or other business meeting, you should also plan to get custom designed name badges or lapel stickers, after all you want everyone to know your name, company name and to see your logo. Other effective uses for name badges and lapel stickers are: business conferences, workshops, chamber of commerce meetings, general presentations and much more.

Before you hit the back button thinking bartering went out of fashion when money came along. Think again. Bartering has not only thrived all this while, it has made a come back in the business world in a big way.

Should Taxi Cab Companies participate in public relations? Sure they should and many do such as taking people home who drank too much on New Years Eve or putting signs on the cabs that warn teens not to do drugs.

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