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Six Sigma professionals have the requisite expertise and experience in implementing Six Sigma projects and their services are necessary for ensuring the suc

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

cess of the implementations. However, not all organizations can afford such services because Six Sigma professionals normally charge hefty fees. The best op

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

Examples of combination products may in

ion then for such organizations is to provide Six Sigma training to their existing employees. Training existing employees not only helps in reducing impleme

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

ntation costs but also ensures that the implementations are completed within the specified time.

However, selecting the most appropriate training course fo

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

employees may not always be easy because of the recent increase in the number of entities offering Six Sigma training courses. The problem is compounded be

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

Combination pro

cause most of the training entities claim to be the best in the business.

Organizations can develop their own training institutes, but this can further com

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

licate the financial health of an organization that is already running short of funds. The best option then is to select the most cost-effective training pr

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

ogram for the employees. Given below are some of the basics that a good Six Sigma training program should always have:

1. The training program should cover

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

important Six Sigma methodologies such as DMAIC (define, measure, analyze, improve, and control) and DMADV (define, measure, analyze, design and verify).

2

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

. The training program should aim at creating awareness about the roles and responsibilities of personnel associated with Six Sigma implementations. It shou

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

d make the employees learn the tenets of effective communications, which is a necessity for successful Six Sigma implementations.

3. The training should co

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

Following aspects would a

er all types of Six Sigma statistical tools such as Critical Path Method (CPM). CPM helps in designing a proper timetable that predetermines the start and c

dd to the challenges in developing combination products:

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

ompletion of key events in any business process. With the help of CPM, employees can easily find out the exact status of various projects by monitoring key

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

vents through the CPM timetable. Other important statistical tools that need to be covered include FMEA (Failure mode and Effects Analysis), which helps in

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

anticipating future problems through analytical interpretations.

4. The training should enable employees to learn the use of software tools such as RapAnal

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

st, which simplifies DOE (Design of Experiments) and many other activities related to data mining; MiniTab and SixNet Intelligence; and the Six Sigma calcul

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

Professional from academic institutions, pharmaceutical industries, health care indust

ator, which is a hand tool. The training should also cover the use of judgmental tools such as Ishikawa Root Cause Analysis Diagram (Fishbone diagram), Brai

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

Storming & Affinity Group Tool, Thought Map, and Regulation Diagram.

5. The training should also enable employees to learn soft skills such as presentatio

.

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 skills and managerial skills such as decision-making. These skills will go a long way in ensuring the success of Six Sigma implementations.

A Six Sigma t

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

Companies that provide selfless information through particip

aining program that covers all the aspects stated above needs to be selected, even if it is relatively more expensive than other available training programs

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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