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Advice You - Why Hire a Security Consultant
I have often been asked, “Why should I hire a security consultant to tell me what security measures my business needs?” I guess the biggest reason is if you know little to nothing ab
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
out security, then you need to hire someone that does know the ins and outs to get the most benefit!
There is a lot more than just looking at your doors, windows and locks or alarm
There is a lot more than just looking at your doors, windows and locks or alarm
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ystems to figuring out what security measures are need to protect your entire business. The main goal is to look at all your liabilities on security issues and reduce or eliminate th
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
em. This saves you time and money in the long run and keeps you out of a possible court situation in the future.
To this end, you need to do a physical site security survey. This wi
To this end, you need to do a physical site security survey. This wi
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
l identify the most pressing of your security issues that can get you in trouble. By looking at the entire company, those issues can be identified, measures to protect you implemente
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
and your liabilities reduced!
There are measures that only need to have policies and procedures changed or implemented that will reduce your liabilities. There are other measures t
There are measures that only need to have policies and procedures changed or implemented that will reduce your liabilities. There are other measures 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
hat you will need to put in place to protect your hiring process that can save you from a lawsuit. Then there may be other measures that contain a security presence on site or after
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
ours that will protect you.
The thing with competent security consultants is, they know what to look for when identifying security issues and they know how to deal with them with co
The thing with competent security consultants is, they know what to look for when identifying security issues and they know how to deal with them with co
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
t effective reductions/eliminations. They know what does and does not work for a variety of business types and your particular area of location.
Security measures do not mean that i
Security measures do not mean that i
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
t has to be a major expense outlay every time. But, it can come to a major expense if you do not have the proper security measures and wind up in a court situation being sued for tha
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
reason. You may have insurance to cover it and they may not cover you if found negligent.
Then there is the bad publicity, the court time, the lawyers fees and on and on. You can s
Then there is the bad publicity, the court time, the lawyers fees and on and on. You can s
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
e it can be very traumatic for a business owner! Especially if you lose the case and very expensive too!
So it makes sense to use a security consultant to get the best benefits you
So it makes sense to use a security consultant to get the best benefits you
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
can, think of the expense as an investment for the future. It will keep you out of court, it could save you on your insurance, it will keep you out of the bad publicity limelight and
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
it will give you piece of mind.
It is better to be prepared and not need it than to not be prepared and need it. This is true for any type of business! Stop looking at security as j
It is better to be prepared and not need it than to not be prepared and need it. This is true for any type of business! Stop looking at security as j
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
st an expense and look at it for what it is, an investment to protect your future!
Consultants can help you with the following issues:
? Negligent Hiring/Retention ? Premises Liab
Consultants can help you with the following issues:
? Negligent Hiring/Retention ? Premises Liab
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
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
ility
? Negligent Security
? Hiring Contract Security Services
? Physical Site Security Surveys
? Business Espionage
? Fraud and Internal Thefts
? Disaster recovery
? Risk Ana
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ysis
There are many ways a consultant can protect your business. You are looking at reducing your liabilities and protecting your self, employees, assets and the facility you have.
There are many ways a consultant can protect your business. You are looking at reducing your liabilities and protecting your self, employees, assets and the facility you have.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
fter all you have worked for a while to get where you are, would it not be silly to lose it all because you thought it was an unnecessary expense?
Publishing Guidelines: You are we
Publishing Guidelines: You are we
.
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
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
lcome to publish this article in its entirety, electronically, or in print, free
of charge, as long as you include my full signature file
for Ezine’s. Please send a courtesy link
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
or email where you publish to secuone@aol.com Thank you.
“Why Hire a Security Consultant” ©2004 By Gary L. Cunningham, C.P.O. C&M Consulting Services ALL RIGHTS RESERVED WORLDWID
“Why Hire a Security Consultant” ©2004 By Gary L. Cunningham, C.P.O. C&M Consulting Services ALL RIGHTS RESERVED WORLDWID
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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