Advice You - Business

Background
I finished my MBA in October 1985 and placed at M/S. XYZ Pvt. Ltd. (the real name of the company is hidden)as a Management Trainee. The Company produces empty containers used by tooth powder, fac

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

e powder and paint manufactures. The process of production of containers was as follows.

Production Process
Tin plate sheets are cut according to the size of the containers and then transferred to coating

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

Examples of combination products may in

nd printing departments where first coating used to be given to the sheets and then as per the buyers instructions, the printing of label, logo, etc. get printed. After drying in the oven, the sheets were shifte

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

to fabrication department to mould and weld the sheets to get the containers. The finished containers will be send to the quality control to check the quality aspects and the good containers will be given to th

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

packing section from where the packed containers will be dispatched to the buyers.

My Assignment
I was posted to the coating and printing department to evaluate the productivity of the coating section. In

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

Combination pro

the coating section the maximum allotted workers were four of which one technical and the rest were non-technical. My assignment was not clear and specific.

Methodology I followed
After going through the d

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

aily attendance record for the previous three month period, I came to know for a good number of days the coating section was run with three workers (one technical and two non technical) also. It gave me an idea

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

o proceed further. I found there were three workers present for 41 days and four workers were present for 49 days of the selected period of 90 days. I collected data of daily production in terms of number of she

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

ts coated when three workers were present and when four workers were present separately. I computed daily average production using arithmetic mean and standard deviation for the two groups. Apparently I found th

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

re was difference. Based on this, I found there was a problem of more number of workers allotted than required. Before formulating the problem I interviewed the workers and the supervisor. In the interview proce

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

s it was revealed that when technical worker was absent, the supervisor used to help and when non-technical worker was absent the workers used to adjust. Of the 41 days, only for three days the technical worker

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

Following aspects would a

was absent. Therefore the average daily production was revised for 38 days for the group of three workers including technical worker were present. This understanding helped me to formulate the problem.

Problem

dd to the challenges in developing combination products:

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

tatement
Does the coating section require four workers including technician?

Solution
To solve the problem, a test of hypothesis is performed by the use of Z test particularly to find the differenc

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

between the two sample means.
Sample 1 when there were four workers including technician
Sample 2 when there were three workers including technician
After the test of the hypothesis it was found

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

hat there was no significant difference in the average daily production between the two samples. This implies that there was one extra worker allotted to that extent the productivity of the coating section was a

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

fected.

Reporting and Execution
The finding was reported to the General Manager (works) and discussed. The method of identifying and confirming the problem was appreciated and discussed with the supe

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

Professional from academic institutions, pharmaceutical industries, health care indust

rvisor. I arranged a meeting by calling the leader of the workers union and the supervisor in the presence of the General Manager and I suggested to transfer one non-technical worker from coating section to othe

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

department where his services are required. The General Manager (Works) as well as the leader of the workers union and the supervisor had accepted and immediately executed. I observed the average daily producti

.

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

n for three months after the execution of the suggestion and did the analysis. It is revealed that the average daily production was same when compared to that of before execution of the suggestion. With this the

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

Companies that provide selfless information through particip

Management was totally convinced. Thus the cost of running the coating section was reduced and was reflected on the productivity of the section favorably. That is how I identified the problem and solved the same

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.adviceyou.org.ua/article/35083/adviceyou-How-I-Solved-Problem-In-The-Beginning-Of-My-Career--A-Case-Study.html">How I Solved Problem In The Beginning Of My Career? - A Case Study</a>

BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/35083/adviceyou-How-I-Solved-Problem-In-The-Beginning-Of-My-Career--A-Case-Study.html]How I Solved Problem In The Beginning Of My Career? - A Case Study[/url]

The marketing job is on of the job titles that really explain what you are doing with the job you are getting. The marketing job will give you the opportunity to sell and advertise a product that a company is trying to sell to the consumer today.

The Key to niche marketing is setting yourself up to be a Big Fish in a Little Pond!

MTL's and BAT's have nothing in common with BLT's or SUV's, but they are part of any great PowerPoint presentation. Here is a glossary of terms used by professional graphic artists and presentation pros that you should know.

Tags

Links

Advice You - How I Solved Problem In The Beginning Of My Career? - A Case Study

Related Articles: