Advice You - Business

Lean manufacturing is a business proposal to reduce waste in manufacturing processes. The basic scheme i

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

s to reduce the costs methodically, throughout the product and production process, by means of a series

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

Examples of combination products may in

f development reviews.

Many companies have now added interactive real-time online seminars also called

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

webinars" to their portfolio of lean training opportunities for organizations worldwide. Webinars cover

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

ey topics required for in-house teams working to implement their lean future state plans.

Lean advisors

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

Combination pro

conduct sessions interactively, answering questions, giving quizzes, challenging assumptions, and leadin

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

group discussions via phone and the Internet, which is advantageous for organizations that work from th

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

comfort and convenience of their own offices.

Participants work as groups in a room with computer acce

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

s, or from their own offices. PowerPoint presentations and other materials are available to help make 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

seminars easier to understand. Discussions also take place over the phone. Using cutting-edge technolog

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

, learners have access to an easy, responsive, and fluid online interface that has proven to be a reliab

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

Following aspects would a

le form of training today.

There are many advantages of in-house seminars. These include receiving a cu

dd to the challenges in developing combination products:

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

tomized workshop tailored to suit the needs of your organization, training 4 to 20 staffers for a reason

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

ble fee, limiting time away from your work schedule, learning together as a team, and working on specifi

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

problems or issues unique to your establishment.

There are many advantages associated with public semi

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

ars. These include pre-workshop questionnaires which tailor the event to the participant's requirements,

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

Professional from academic institutions, pharmaceutical industries, health care indust

learning from experiences and the opportunity to network with other managers, training away from the wor

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

environment, participating in group problem-solving exercises, and the opportunity to ask questions and

.

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

work on specific issues unique to your establishment.

To figure what's best for your organization, cons

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

Companies that provide selfless information through particip

der all training programs offered today, and reap benefits with the help of this new manufacturing trend

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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