Subjects - Business

This article is written for team member who are either not formally trained in using the MS Excel spreadsheet or not even read a training manual in using MS Excel. But they are requir

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

ed to deal with data collection and compilation in their routine job or in this TQM Improvement project.

I am sharing this because as a facilitator to TQM Improvement Team, I have se

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

Examples of combination products may in

n team members spend unnecessary time dealing with data collected and managing these data. To appreciate the content of this article, reader must understand the basics of MS Excel in

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

erms of terminology, example; menu, scroll bar, cell, row and column etc. I am going to share with your some of the common mistake that my team members did without knowing they can c

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

t down up to 80% of their time. Firstly, I like to cover the following topics.

Layout of the worksheet

Very often, the first row of the worksheet is used up for a title of th

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

Combination pro

spreadsheet. Let’s say we call it "Material Loss Report". In some case, team member use up more than 3 rows. Then several rows are left blank, the title is keyed in say in row 5. The

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

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

| 231 |

Data Entry Method

Having properly designed layout in the spreadsheet would save a lot of time in data entry using some of the build in functions in MS Exc

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

l. An effective data entry would result in data accuracy and integrity which is very critical for an improvement project.

Here is what I meant; Often, team members would move their c

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

rsor into the spreadsheet to do data entry within the format they created. It is not an issue when the spreadsheet is still small can contain not too many row or column. However, it

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

ill become very tedious when the number of row and column increases. Next issue is that data entry into the spreadsheet direct from the format will create data entry error due to fati

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

Following aspects would a

ue.

What is the option then, it is simple. Use the build in function in the "data" menu, click on the "form". A form will appear that show the title above in the nice format for eas

dd to the challenges in developing combination products:

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

for data entry. When data is completed for one record, you click the close button, the data will automatically updated to the spreadsheet.

While you are still in the form, options a

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

e available to add new record, Find Prevrecord; find Next record; or close the data entry form etc. It is a smart and simple build in function to use for

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

data entry.

Please click To View Graphic explanation of Data Entry Form

My next article wil

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

share with you tips on how to do a fast quality control with your data spreadsheet.

----------------------------------------------------------------

Disclaimer:
All ri

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

Professional from academic institutions, pharmaceutical industries, health care indust

hts reserved. This article is written by the author based on his practical application experience. All definitions and interpretation of terminology are his point of view and has it h

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

s no intention to conflict with experts in similar topic. The author holds no responsibility for the use of this article in any way.

-------------------------------------------------

.

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

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

Companies that provide selfless information through particip

f this article. Please ensure that the URL in the resource box remain intact and it is linked to the author's website.

---------------------------------------------------------------

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.subjects.org.ua/article/22498/subjects-Managing-Data-Analysis-in-TQM-Improvement-Project--Tips-to-Cut-Down-80-of-Time-Spent-in-Data-Entry.html">Managing Data Analysis in TQM Improvement Project - Tips to Cut Down 80% of Time Spent in Data Entry</a>

BB link (for phorums):
[url=http://www.subjects.org.ua/article/22498/subjects-Managing-Data-Analysis-in-TQM-Improvement-Project--Tips-to-Cut-Down-80-of-Time-Spent-in-Data-Entry.html]Managing Data Analysis in TQM Improvement Project - Tips to Cut Down 80% of Time Spent in Data Entry[/url]

Everyone is outsourcing non-critical tasks to India, and for mid-sized companies, a trip there for the purpose is de rigueur. This two part article describes in detail the planning one needs to do to maximize the success of that journey...

A certain sense of self evaporates when you lose your job because so much of your identity is intertwined with your profession or craft. Strategies to maintain a sense of self-worth despite temporary employment is outlined.

When setting up a car wash fundraiser is very important to keep the workflow moving. If you have sold a lot of presale tickets or if your car wash fundraiser is on a busy corner in the city then you will no doubt have many cars lined up waiting to be washed.

Tags

Links

Subjects - Managing Data Analysis in TQM Improvement Project - Tips to Cut Down 80% of Time Spent in Data Entry

Related Articles: