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Six Sigma is a continuous procedure, which can help companies reduce the over all expenses and expenditures, and increase profits by streamlining operations, improvin

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

g quality and eliminating all the problem areas. Not only does Six Sigma benefit an organization, but also the organization can benefit Six Sigma by managing it. Mana

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

Examples of combination products may in

gement must be led by highly qualified and trained individuals.

Managing a Six Sigma team is not an easy task and it is fairly impossible for a single person to mana

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

ge a Six Sigma project on their own. Six Sigma is a team process that requires teamwork at most levels. Managing a Six Sigma team starts from the uppermost levels of

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

the organization. The company's leaders must provide resources to the teams and the authority to apply these Six Sigma concepts in their day-to-day activities. Compan

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

Combination pro

y leaders must also ensure that the company goals are associated with Six Sigma projects and they must see to the removal of any obstacles that might stand in the way

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

of Six Sigma deployment.

Selection And Training Of Six Sigma Team Leaders

Six Sigma team leaders need to be properly selected and trained, as they play a crucial r

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

ole in the management of the entire team. Not only are they responsible for managing the team, they are also the main change representatives for the Six Sigma process

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

. Six Sigma team leaders are directly responsible for managing their teams. A Six Sigma Black Belt is the team leader and the responsibility of the Black Belt is to f

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

acilitate Six Sigma as part of the culture.

Black Belts need to be trained in Six Sigma methodology and they must have prior experience in leading teams. The Six Sig

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

ma team leader or the Black Belt must have leadership qualities, they should be able to understand the team dynamics and should be able to assign to each team member

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

Following aspects would a

their individual roles and responsibilities. They help the teams achieve and sustain noteworthy results.

Important Aspects Of Managing A Six Sigma Team

Leading and

dd to the challenges in developing combination products:

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

mentoring are the two most important aspects of managing a Six Sigma team.

As the leader, the Black Belt should be willing to adjust to circumstances. They should be

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

able to recognize and manage occasional setbacks. By directly being involved with the team, the Black Belts help implement improvements in a quick and efficient mann

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

er. The main role of the Black Belt includes minimizing group conflict and handling out-of-control meetings. Six Sigma includes practices that substitute hasty, impru

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

dent habits with a dynamic, open and practical method of management.

It is important for the team leader or the Black Belt to be a mentor to everyone on the team. Af

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

Professional from academic institutions, pharmaceutical industries, health care indust

ter their training, new candidates must be given proper guidance. This ensures the timely completion of projects and regular corrections being made in the course. Six

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

Sigma supports teamwork and the Black Belt should work towards creating a healthy and productive team environment. The Black Belt should arrange the team in such a

.

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

way so as to best utilize the individual knowledge and techniques of the individual team members. Black Belts should help improve and increase members’ morale. Every

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

Companies that provide selfless information through particip

circumstance should be regarded as an opportunity by the Black Belt to help guide and instruct the individual team members and to improve the organization as a whole.

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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One of the most serious considerations in mining or collection of raw materials is the transporting of these resources to processing or market. Same for oil, natural gas or mining materials; costs of transportation are important in mining. Most mines still in business today are in very close proximity to major rail lines, even with all the regulations and rules that exist some mining still exists in the United States. An example is the Borax Mine near Dagget, CA.

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