Advice You - Business

I used the word develop, not write on purpose in the title of this article. While your Operations Manual, Ops Manual, is a crucial tool in your Internal Management tool kit, you don't really w

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

rite it.

Instead you collect it. You gather in one place lots of the bits of information your business depends on to run smoothly, face crises calmly, and allow you to back fill in a hurry. W

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

Examples of combination products may in

th a complete Ops Manual in place, you, or someone you designate, can act quickly to serve a client, get you out of a stuck spot, carry on when you're unavailable. You get the idea. Major Beer

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

Truck insurance.

With a good Ops Manual, you'll never again search for the product code or password for your software, miss a deadline for domain registrations, lose the number of the ink for

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

your letterhead, or the contact number for crucial vendors and suppliers.

Get started by adding an electronic sub-folder to your version of "My Business Administration" folder on your hard dr

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

Combination pro

ve. Then start an electronic "Ops Manual" document (which you will print out in case of power failure, right?). Format the text with header style so you'll be able to quickly add a table of co

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

tents when you're finished. By adding a header and a footer with title, page numbers and file name and path (look in the auto text option in the header/footer format window of MSWord) you'll b

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

able to find and navigate through the paper and electronic file so much faster. Then start adding sections and details.

ADMINISTRATIVE:

Administrative details can include a data base file t

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

keep track of

a. your vendors and suppliers

b. sources and product numbers for key supplies

c. details from major purchases, cost, source, depreciation records, and serial numbers

d.

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

nsurance policies and coverage details

f. equipment and software, price, source, serial numbers, warrantees, service numbers, manuals and spare/extra parts

g. electronic back ups, where st

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

red off site and on site h. opportunity preparation, passport, cash, credit card accounts and # to call if lost or stolen

f. most important of all…your file on files, a list of where you k

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

Following aspects would a

ep what (cuts down on major time lost for hunts for crucial details

POLICIES AND PROCEDURES:

a. your approach to financial planning and expenditures; your budget, and an empty copy of your

dd to the challenges in developing combination products:

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

ne-page financial summary

b. intellectual property

c. customer service

d. vision and values e. procedure summaries, including how to do what needs to be done, step by step instructions f

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

r crucial activities, key contacts, forms and files

f. if you use subcontractors or have employees…all the files and information you'll need to stay legal, job and position descriptions, emp

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

oyment and compensation records, subcontractor contracts and policies

g. how to deal with money and mail coming in and money and mail going out

h. you'll also want to keep any electronic c

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

pies of policies and procedures in this central location

All of this gets summarized into your Ops Manual. I usually add a table of contents to the electronic file, and then print out a hard

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

Professional from academic institutions, pharmaceutical industries, health care indust

copy, the location of the electronic files noted on the inside of the front cover. And, of course, press a cd of the whole manual and its back up files. They go with the get away kit near the

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

oor so I can keep it in my portable office, and then a fuller version on the hard drives of both my laptop and desk top. Of course it's also included in my back ups kept on site and off site.

.

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

Be prepared to move in a minute...if the need or the opportunity arises.

(Someone said I am paranoid about this...you bet! I live in earthquake country. The value in my electronic files is th

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

Companies that provide selfless information through particip

information not the hardware its sits on. If I have to go in a minute, I want my business with me.)

Want more information about how to develop the tools to run your business more effectively

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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Only you know what your capital reserves are and what type of reserves your business will require from month-to-month. While some businesses are more sophisticated than others, only you have access to the full spectrum of your financial position today and the forecast of what responsibilities there are to come. It is not only essential that you prepare yourself adequately; it's crucial.

First Bank of Nigeria Plc on Tuesday began the process of raising fresh funds from the market with an application to the Nigerian Stock Exchange. The bank applied to offer 1.6billion ordinary shares of 50 kobo each to be sold at N33 per share for public subscription and 1.5billion ordinary shares of 50 kobo each at N31 per share as Rights Issue to existing shareholders.

Your Visual Vocabulary consists of the secondary design elements that are used in conjunction with your logo to form your brand identity. Your Visual Vocabulary is composed of the graphics, font styles, colors, and even the type of paper you choose. Once you have determined the elements to use in your Visual Vocabulary, it is important to use those elements consistently throughout all of your marketing materials.

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Advice You - Develop Your Ops Manual

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