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The need for Six Sigma training has arisen following two reasons. One, the demands of industry could not be met with the existing limited quality assurance methods and two, the

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

tremendous financial opportunities for corporations that the 6 sigma methodology is creating of late. Many well-known organizations have developed their own Six Sigma training i

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

Examples of combination products may in

stitutes, for in house training of their employees. Realizing the demand that could not be met by companies by themselves, many training institutes and universities have come fo

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

ward and developed basic Six Sigma training courses.

Differences In Six Sigma Training Basics

A quick look at the Six Sigma training course contents of various institutes imme

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

iately shows that they vary widely in their central focus, while still keeping the fundamentals of Six Sigma training content intact. However, this is hardly surprising when one

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

Combination pro

realizes that corporations devise courses for training their own employees for more flexibility. However, the Six Sigma training curricula prepared by independent training insti

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

utes and universities closely resemble each other, brining credence and uniformity to all Six Sigma training.

The Basics Of Six Sigma Training

Differences notwithstanding, the

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

central theme of Six Sigma training required for certification must remain same. These are the six core basic elements of Six Sigma training:

1. A thorough and complete trainin

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

on the DMAIC process and 6 sigma methodology: This involves familiarizing trainees on statistics and its applications, the five key elements of the DMAIC process, and the imple

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

entation of this methodology.

2. The roles of each key person: Each person in the organization plays a critical role in the implementation of 6 sigma. Thus, Six Sigma training

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

eeds to focus on understanding the key elements of every person’s role and the skill to communicate with key players across the organization.

3. Developing abilities to define

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

Following aspects would a

nd work on projects: In Six Sigma training, the emphasis is placed on the streamlining of processes, focusing on the core competencies of each of these. Six Sigma training also

dd to the challenges in developing combination products:

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

ocuses on identifying and developing breakthrough processes, products and/or services. As a result, root cause analysis and crisis management abilities become the key to develop

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

ng versatile management abilities.

4. Cross training necessity: The deployment of Six Sigma methodologies puts the emphasis on a team-based approach. Naturally, qualities such

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

s interpersonal skills, ability to communicate effectively, and ability to transfer knowledge and clarify issues are also important. Sharing of knowledge across the organization

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

is crucial for to the success of 6 sigma implementation.

5. Problem Solving Tools: In Six Sigma methodologies, problem-solving tools are statistical. Six Sigma training essenti

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

Professional from academic institutions, pharmaceutical industries, health care indust

lly teaches all those involved in the implementation how to use statistical tools in order to analyze a problem and solve it. Six Sigma training techniques assume that all candi

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

ates do not necessarily have formal training in statistics.

6. Presentation and closing techniques: In Six Sigma training, everyone is taught how to make presentations to manag

.

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

ment and other decision-makers. Six Sigma training also focuses on how to make the transition to closing projects after their conclusion or abandonment.

All Six Sigma training

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

Companies that provide selfless information through particip

bjectives are tied to a quality-first policy. In a nutshell, Six Sigma training instructs students on how to dissect information, analyze it, validate the results, and implement

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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