Main Subject - Business

Business organizations all across the globe are deploying Six Sigma concepts and techniques for improving the quality of their products or services. This has created the need to educate employe

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

es about the various Six Sigma concepts and techniques that improve quality and help in offering better products and services than those offered by competitors. This is necessary, as quality pr

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

Examples of combination products may in

oducts or services are primary requirements for the long-term success of any business organization.

Training Is Necessary

Any company planning to empower its employees with the various Six Si

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

gma concepts and philosophies needs to enroll them in a Six Sigma program for getting the requisite training and qualifications. However, companies often become confused when it comes to select

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

ing the most appropriate Six Sigma program. Conducting online research does not help in solving matters, as search results list thousands of training organizations, most of which are labeled as

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

Combination pro

'premier', 'best' or 'rated # 1'. For selecting the most appropriate Six Sigma program, companies need to look beyond the labels and concentrate more on the details of the training program.

Ho

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

w To Select The Right Training Process

Companies need to decide whether they need a standardized certification program or a simple learning program that imparts basic knowledge about Six Sigma

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

. If certification seems necessary then it is important to ask training organizations about the type of certification provided by them and their student pass rates. Companies often send their e

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

mployees for training in batches and as such only those training organizations need to be short listed that offer discounts on training large number of candidates. Expenses on training can be l

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

owered even more by entering into a contract with the training organization.

Venues For Training

A program that can be conducted off-site in the same town or nearby area is far better than pr

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

grams that are conducted far away from the company's location, as costs of hotels, airfare, meals, and others can increase overall training expenses. Companies need to ask potential trainers ab

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

Following aspects would a

out the type of resources that they use in their training programs and how much of it can they bring along in case of off-site training.

Due Diligence

Companies need to interview potential tr

dd to the challenges in developing combination products:

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

ainers and ask questions regarding their past corporate relationships, referrals, total number of candidates trained by them till date, training materials used, earlier projects they have worke

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

d on, and their qualifications. This is necessary, as companies want trainers that have a great deal of real-world experience. Spending thousands of dollars on learning something that can be le

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

arnt by just reading books will certainly be a waste of money and effort.

Six Sigma programs are classified according to their depth and specialization. Just as in martial arts, white belts, y

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

llow belts, green belts, brown belts, black belts, master black belts, and champions represent Six Sigma levels. Programs offered may include DMAIC, DFSS, Lean, Kaizen, Fishbones, SIPOC's, Mini

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

Professional from academic institutions, pharmaceutical industries, health care indust

Tab, Process Maps, SAS, Change Management, Force Field Diagrams, and Project Management. Companies can select any one of these or a combination of these depending on the level of specialization

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

that they think is necessary for achieving the desired Six Sigma goals and objectives.

Some Cautions

Companies need to make sure that the individuals who provide training are the same ones w

.

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

ho have been interviewed. This is necessary because often, training organizations try to woo potential clients with their most competent trainers and actually send junior level professionals wh

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

Companies that provide selfless information through particip

en the contract is signed. A lot of money is spent on training employees. Therefore, it is necessary to consider every detail before signing the training contract with the training organization

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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