Useful Advices - Business

Written Hazard Communication Program.

Very important, but, don't be intimidated by this requirement of the standard. The written program need not be lengthy or complicated, yet it is likely to be one of the first things an OSHA ins

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

pector will ask to see during an inspection. The written hazard communication program needs to be specific to your workplace, and it must describe the methods the employer will use to inform employees of the hazards involved in routine as

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

Examples of combination products may in

well as non-routine tasks performed. The written program must outline the procedures the employer will use to meet the requirements for Hazard Communication as follows:

MSDS - how they are addressed & used in the workplace.

Label

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

ng Practices - of hazardous chemicals and substances you work with, including any other form of warnings (such as signage for hazardous areas or conditions).

An Inventory List of Chemicals - that are used at your workplace and jobsites, id

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

ntified as they are referenced on the appropriate material safety data sheet (you may compile the list for the workplace as a whole or for individual work areas).

In Multi-Employer Worksites - the method the employer will use to provide th

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

Combination pro

other employer(s) all precautionary information or measures that need to be taken to protect those employees (if exposed) from hazards such as; the production, use, or storage of hazardous chemicals or conditions present, and likewise when

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

an employer will be working in your area.

Training in the methods, practices, and observations which employees are to use in the recognition of actual and (or) potential health hazards, and measures they should take to protect themselves

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

nd others. Ongoing and updated training sessions provided by the employer must also provide to the employee a clear understanding of the overall "HazCom" program and their role in it.

Employee Training.

Training of your employees

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

n all areas of Hazard Communication in your business on a regular basis is critical to the success of the entire program. The requirements regarding training are as follows:

Employers shall provide to their employees information - by mean

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

of training on hazardous chemicals/ situations in their work area[s] at the time of their initial assignment, and whenever a new hazard is introduced into their work area.

The hazard communication standard - and it's requirements must be

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

ddressed as part of employee training.

Employees shall be informed of the location and availability - of the written "HazCom" program, including the required list of hazardous chemicals, and MSDS applicable to their work area(s) or job sit

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

Following aspects would a

es.

MSDS - proper usage, understanding, and availability must be covered as part of their training.

Each employee shall be trained - in the methods and observations that may be used to detect the presence or release of a hazardous chemica

dd to the challenges in developing combination products:

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

, including the physical and health hazards of those chemicals in their work area.

The measures employees should take - to protect themselves, including procedures the employer has implemented to protect employees from such hazard exposure

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

for example, appropriate work practices, emergency and evacuation procedures when applicable, and personal protective equipment to be used.

The details of the "HazCom" program - developed by the employer, an explanation of the labeling sy

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

tem and material safety data sheets, multi-employer worksite procedures, and how employees can find and use the appropriate information.

In a situation where employees are exposed to a small number of chemicals in the workplace, the employ

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

r may discuss the particular hazards of each one. Where there are large numbers of chemicals, the training regarding hazards could be done in categories (e.g., flammable liquids, carcinogens, etc.). Either method would be acceptable. In

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

Professional from academic institutions, pharmaceutical industries, health care indust

ither case, the employees are to be referred to information on product labels and MSDS.

Re-training shall occur when - the hazard changes, not just when a new chemical is introduced into the workplace. If the new chemical has hazards whic

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

employees have been previously trained about, then no re-training is required. If the chemical has a hazard they have not been trained about, then re-training is necessary but limited to that hazard.

Note: Employee training should includ

.

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

all areas of your "HazCom" program including the written program. Make sure each employee has received a complete copy and has read and clearly understands it.

Note: Document your training sessions regardless of the duration, list the e

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

Companies that provide selfless information through particip

ployee name(s), date, time, place, subject or topic covered etc., and have each employee in attendance sign-off on an attendance sheet. Keep these records for future reference and as a guide for on-going training periods and subject matter

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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Many of us are familiar with at least the concept of bulletproof and bullet resistant glass, but for most of us these concepts play little role in our day to day lives. Even so, this powerful and potentially life saving technology is important in a number of locations, including some you may not have been aware of.

Most of the time project management is the concept that is majorly used to efficiently use and manage the resources the way they are supposed to be handled. Projects are generally the starting point of a future product or service which builds up with time as the project projections and outcomes comes out positive as expected.

It is a puzzle to me why so many organizations do such a poor job of blending the cultures of the two merged organizations into an effective, focused, and successful new corporate entity with a clear direction, culture and personality.

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Useful Advices - Hazard Communication Basics Part 2

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