Advice You - Business

This article relates to the Safety and Working Environment competency and explores how your employees feel with regard to their physical and environmental working conditions, the quality of their equ

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

ipment and tools, and overall attention to safety within the workplace. Every organization is responsible for ensuring the health and safety of their employees. An unsafe working environment can lead

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

Examples of combination products may in

to accidents, lawsuits, and missed work. Such incidents can result in significant costs to your organization. The questions included in this competency will investigate whether your staff is satisfie

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

d with the organization's facilities, whether they believe business is being conducted in a safe manner, and if the tools and equipment provided are adequate to successfully and safely complete their

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

jobs.

This article, Improving Workplace Safety, is part of AlphaMeasure's compilation, Tales From the Corporate Frontlines. It tells how a company, shaken by a workplace accident, made a concerted e

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

Combination pro

ffort to improve workplace safety conditions and enjoyed multiple benefits as a result.

Anonymous Submission

Improving Workplace Safety

For a small business owner like me, creating an accid

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

nt-free workplace is a huge undertaking. Recently, I discovered just how important an undertaking it was. Insurance is expensive enough these days, and I had been trying to do everything possible to

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

keep premiums down. I have a limited number of employees, so it's crucial to maintain a high level of productivity. At the end of every month, I would breathe a sigh of relief when we avoided unneces

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

ary accidents and the resulting down time.

Then, two years ago, one of our employees was involved in a serious accident. She was hospitalized for weeks and the line she worked on was closed for insp

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

ection by insurance adjustors and further inspection and repair. At that time, I decided that an in depth review of our company safety procedures was in order.

The first thing I did was to complete

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

n employee survey. This helped in several respects: employees gave feedback about the work environment and pointed out areas where safety concerns existed, and it gave them a useful way to help make

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

Following aspects would a

sure that a similar accident would not happen. Once the survey was finished, a memo was circulated to remind employees that their reports of any safety concern at any time were most welcome and appre

dd to the challenges in developing combination products:

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

iated.

Using the feedback gained from the employee survey, I determined which basic safety training areas needed to be revisited. Some of the newer employees had not yet completed the mandatory trai

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

ning, and the long term workers had done it so long ago that they would surely benefit from a review. So we set up a schedule and everyone underwent job specific safety courses.

Finally, the employe

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

survey indicated that an employee safety incentive program might go a long way toward preventing future occurrences. I considered the cost versus the benefits, and decided that the idea was worth a

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

try. We began with a monthly incentive program that awarded a small merchandise prize or a gift certificate for a local business. Then we added a prize for workers that were accident-free for a speci

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

Professional from academic institutions, pharmaceutical industries, health care indust

ic period of time. Some employees felt that we needed to post reminders, and they created posters. After a while there was a contest for the most creative idea and best artistically rendered safety p

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

oster. There were also periodic pop quizzes on safety procedures with prize rewards.

The total company process of improving our workplace safety resulted in more than just fewer injuries. The effort

.

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

produced a team spirit, employees enjoyed a safer environment, and morale received a boost. Add in greater productivity and savings on insurance premiums, and both company and employees were big winn

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

Companies that provide selfless information through particip

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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If you are trying to implement a business process management strategy, then you might have found that there can be difficulties involved. Getting the balance right between effective business management of people and using business process management software can be hard. However, there are ways to get round these business process management difficulties. If you are looking to improve the efficiency and productivity of your business and its daily processes, then here is some advice about the difficulties of implementing business process management.

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