New FDA website from May 30

The FDA Web Site will be changing on May 30



The new site organization is intended to allow you to find information more quickly:

1. Information is categorized by topic for easier retrieval, with related subjects consolidated in sections on the site.
2. Page design and navigation have been updated and are consistent throughout the site.
3. Content has been reviewed for relevance, with redundant and outdated content removed.

Schedule of the ICC Twenty20 Cricket World Cup 2009, T20 World Cup 2009, England | rediff.com

Schedule of the ICC Twenty20 Cricket World Cup 2009, T20 World Cup 2009, England | rediff.com

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Helpline to protect Indian Students in Australia

Helpline launched to protect Indian students from violence

In the wake of rising incidents of violence against Indian students in Melbourne, a new helpline service has been launched to protect them and improve their personal security.

The helpline number - 1800, which came into effect on Friday, is the initiative of community members known as Police Indian Western Reference Group (PIWRG).

Attacks in Australia on Indian Students why !

Are Australian authorities taking steps to protect Indian students following a series of brutal attacks in Melbourne that have left the victims in hospital.

Australian police say there have been 500 cases of assault on Indian students in the past six months, perhaps triggered by unemployment.

In fact, the Australian government’s $3.5-million campaign to attract Indian students-in an effort to combat recession-could remain a non-starter if the issue of racial attacks is not addressed. An estimated 95,000 Indian students joined Australian institutions of higher education in the first 11 months of 2008.

Source: BusinessWeek

Cytology Means ?

Cytology Means - :

The medical and scientific study of cells. Cytology refers to a branch of pathology, the medical specialty that deals with making diagnoses of diseases and conditions through the examination of tissue samples from the body.

FDA Warning Letters to Pharmaceutical Companies in 2009

Warning Letters and Untitled Letters to Pharmaceutical Companies in 2009 here you will get the following information-

1. Product/Issue
2. Company/Individual
3. Division/Office
4. Released Date
5. Posted Date

http://www.fda.gov/cder/warn/warn2009.htm

Tax-saving instruments

Here are the few tax saving instruments which select the best and save tax :)

Tax-saving instruments

Insurance:

All payments made towards both life and health insurance are eligible for tax benefits. Even contributions made towards pension payments can be eligible for tax benefits. Health insurance can let you save Rs. 15,000 over and above the ceiling of Rs. 1 lakh.

PPF:

It is one of the safest tax saving investments available. Both interest and capital withdrawal from the fund are tax free. However its drawback is the lock-in period of 15 years.

NSC, Post office (CTD) accounts: These are government savings schemes available at post office, with a lock-in period of 5 years.

Bank deposits:

These are special tax saving FDs offered by banks with a lock-in period of 5 years.

ELSS:

These are tax savings instruments offered by mutual funds, with a lock-in period of 3 years. They invest in various quality stocks.

To know more about ELSS click here
Source: Rediff

Ways to Save tax smartly if Salaried?

Below listed question will guide you to save tax in much smarter ways

Q1. Do you need a house? Does your employer offer Rent Free Accommodation or House Rent Allowance?

Then go for it, as the amount gets deducted from your total taxable income.

Q2. Does your company expect you to wear uniform at work?

If so, the expenses incurred on buying and maintenance the uniform will not be taxed.

Q3. Does your employer provide you with allowance for your children's education and hostel accommodation?

Then use it to claim exemption under section 10 (14).

Q4. Does your company provide you with a telephone facility in your home?

Then it is not taxed. However, be warned against taking telephone allowance, since it is totally taxable and will increase your taxable income.

Opt for the car facility, since the value of the perk is much lower than the actual expenditure incurred on the car.

Also try to restructure your salary in smarter way

1. We all have to visit the doctor at some point of time. So save tax by claiming medical reimbursements up to Rs15,000 per annum. But don't take any medical allowance, since it is completely taxable.
2. If your employer pays Fringe Benefit tax (FBT), then sum of fringe benefits, is tax-free for you. Also, if salary is paid in arrears or in advance, claim relief under section 89 (1).
3. Always ask your employer to include dearness allowance and dearness pay along with commissions earned in your salary. It will lower your tax liability on house rent allowance, gratuity and pension.
4. If you are eligible for a pension, always get it commuted, as commuted pension is tax-free for government employees and partially exempted for others. You can get tax relief under section 89(1).
5. If your current employer is participating in an authorized provident fund, and you change your employer within 5 years of joining the firm, ensure your new employer is also a member of the authorized provident firm. It will let you transfer the corpus in your provident fund to the new company without paying any tax. Also insist your employer fix his contribution to your provident fund to 12% of your salary, as it is the highest limit for tax exemption.
6. Plan your retirement or resignation at the start of the financial year in order to lower the tax on retirement benefits.
7. As leave travel concession is not taxed if certain criteria are fulfilled, try to claim this incentive to the highest possible level, without having to pay any tax.
8. Let us assume your annual salary is Rs 200,000. You get HRA of Rs 10,000 and your medical reimbursement is Rs 5,000. Your employer gives you an allowance of Rs 15,000 for your son's educational expenses. So instead of Rs 2,00,000 your total taxable salary now becomes Rs 170,000 (200,000 - 10,000 - 5,000 - 15,000). This will effectively reduce your tax liability.
9. Now that we have seen how to design your salary let us take a look at the most effective tax saving instruments available.

Source: Rediff

Upcoming Pharma and biotech webinars/training

Check Pharmaceutical and Biotech webinars

Compliant GCP (Good Clinical Practice) Studies – Working with a CRO

Learn here

• Steps to meet the sponsors requirements.
• How to know - are GCPs being followed and is it documented.
• Know the “relationships” - QA, Clinical and the CRO.
• The Audit (aspects and specifics).
• How to do an audit follow-up.
• Post CRO Assessment - How

Objectionable Microorganisms: Considering the Risk

Learn here

• What is an Objectionable Microbe?
• Pathogens vs. Objectionables.
• Just how objectionable is it?
• Consider the risk.
• Performing a risk assessment.

Advanced Topics in Good Documentation for GXPs

Learn here

• The documentation practices that enhance study integrity, repeatability.
• How to prevent 483 items related to data documentation.
• The main documentation errors seen and cited by the FDA.
• Why GLP serves as a good foundation for clinical studies, GMP, and even research.
• Tips for documentation in lab notebooks.

Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers

Learn here

• Undertanding Japanese culture in context of JPAL.
• Risk adversity in the MHLW, PMDA and filtering down to the MAH.
• Language: Translations, interpretations and resulting gaps.
• Technical differences - How to respond and persevere.
• Culture differences - Sometimes we just have to go along.
• Submission data - Best practices for common understanding.

Basics of testing associated with sterilization validation and routine processing

Learn here

• What are the appropriate types of tests during sterilization validation.
• What standards should be used for the testing.
• What type of samples and sample sizes should be used.
• What testing needs to be performed routinely.
• What frequency of testing is recommended.
• What methods can be used to reduce testing.

Source: ComplianceOnline

Compliance Questions ? get answers @ ComplianceOnline.com

Get your toughest Quality and Compliance problems solved by world renowned experts. Ask a question and get multiple answers from multiple experts and users and choose which one best solves your particular problem.

ComplianceOnline Answer

New vs pre-owned Car which one to Buy

The Indian car market is on a roll. While mature auto markets like the US and Europe grapple with the worst crisis in decades, the Indian auto market is racing ahead with gusto. Car sales figures are in overdrive, but interestingly, a large percentage of that growth is being driven by used cars.

Second-hand cars or pre-owned vehicles have really come into their own in the last few years. Gone are the days when a second-hand car was a sureshot sign that you couldn't afford a new one, or when used-cars were looked down upon as poor cousins of the 'new car'.

Today, the market is flooded with incredible used cars -- not very old, not run much, and almost as good as new. Interestingly, there is no dearth of buyers who are choosing to purchase a used car over a new one.

veriCAR is India's first independent used car inspection and certification company. veriCAR uses its expertise to help used car buyers make better purchase decisions, and ultimately enables them to buy the right car, at the right price.

Some of the websites which will help you to select pre-owned cars

1. http://www.automartindia.com/
2. www.indiacar.com/buyused.asp
3. http://www.carazoo.com/usedcars
4. http://www.indiaautomall.com/index.php?page=en_Cars

Advantages of a new car

Unlimited options and wide choice

You can choose your brand and your model. You can choose what colour you want the body to be. And you can choose the colour of the seat fabric. Some new (and expensive) models give you the option of completely customising every detail on the vehicle, making the car a reflection of 'you'.

That 'new car' feeling

Let's face it, few things come close to the smell of a new car. Everything on a new car is, well, new. And that is what most people dream of owning -- a new car, untouched by anyone else, straight off the assembly line.

Peace of mind

New cars are covered against manufacturing defects and faults by the manufacturer for 12-18 months. Also, since the car has not been used by anyone else in the past, it has no secret history for the buyer to be wary of. The condition and price of a new car are transparent, and that makes the deal slightly less risky as compared to a second-hand car purchase.

Disadvantages of a new car

Depreciation depression

New cars lose value really quickly. This loss of value slows down as the car gets older. That's slightly counter-intuitive, but it's true. Some models are known to lose up to 40 per cent of their value in the first year alone.

Money, money, money

The new car feel comes at a cost. You end up paying for insurance, registration, taxes and accessories -- none of which really have any value when you decide to sell your car a couple of years down the line. Basically, most of these expenses are compulsory expenses that you must incur because it is mandatory by law.

Advantages of a used car

Cheaper to buy

Used cars are usually significantly cheaper. Plus you will not incur registration and taxation costs. If you decide to buy second-hand, you can get the same car (say a Getz that Rakesh wants) at a far lower price, or you can buy a bigger, better car (say a City, that Arun wants) for the same price.

Cheaper to own

A used-car has already lost a big chunk of its value, and is going to depreciate much slower in the next few years. That has a positive impact on the cost of ownership, and you lose far less over the three years that you will own the car, as compared to a new car.

No additional expenses

When you purchase a used car, you are paying for the car on an as-is-where-is basis. You don't incur any additional expense on accessories like seat-covers, floor mats, fog lamps and a decent music system. In all probability, the first owner has already done all this for you.

Disadvantages of a used car

Perceived risk

You don't know how the car has been driven and maintained. You are not aware of its accident history. You are putting a large portion of your hard-earned money on a transaction with a guy you have just met. This can be scary. But if you get the car inspected, checked and verified by a competent, independent authority, you have information on your side. And then you have nothing to fear.

Possible expenses on the car

You might have to incur some expenses on servicing the car, setting things right and repairs if required. The wisest thing to do would be to keep away from a car that comes with baggage, and buy one that has been kept lovingly. Once again, a competent person who knows cars inside out will be able to help you with everything you need to know. Most people take a trusted mechanic along, or a friend who knows a little bit about cars. There are professional services you could choose to help you out with this information.

Limited choice

You will probably not get as much choice and flexibility in customisation as you get with a new car. You might have to make your peace with that white Honda City, even though you would really have liked to have a golden one.

Facebook spam again hits

Have you been hit like millions of Facebook users by a new phishing scam that can result in crashing your computers or mobile phones and steal your passwords? If not, beware, do not open the files ending with ".at" or ".be".
How it is running

The phishing scam is being run through the spam messages which steal sensitive information of the Facebook users.

In the attack, the messages are circulated with a subject line of "Hello" and a prompt to check out "areps.at" or other URLs ending in ".at".

The mails with the subject line "Look at This" and links like -- goldbase.be, greenbuddy.be, silvertag.be, picoband.be -- leads to some malicious Web sites, which if visited, could secretly download malware onto computers through a "drive-by download" application.

The URL connectivity, before being blocked directs the visitor to a fake Facebook page and the mail ID and password are stolen as soon as it is logged-in again.

What you should do immediately

According to the All Facebook blog.Facebook, the password in such cases should be changed immediately and the same message should be sent across to one's Facebook acquaintance.

Facebook To get the word out about how to avoid phishing scams and other threats, we’ve launched this series of ads on the site with tips for keeping your account safe. Make sure you’re following all of these practices, and for more advice, become a fan of the Facebook Security Page at http://www.facebook.com/security.

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Airtel Net PC for Rs 8000 only

Bharti Airtel, Asia’s leading integrated telecom service provider, today announced its entry into the cloud computing space with the launch of Airtel Net PC – a low-cost online computer for its broadband customers.

The Airtel Net PC is a ready-to-use computer – inclusive of a 15 inch LCD monitor, keyboard, mouse and Nivio companion – offering just about everything a PC does at a fraction of the cost. It is available at only Rs. 7999 exclusively for Airtel broadband customers in Delhi, Gurgaon and Noida.

The Airtel Net PC is a plug-and-play online computer, inclusive of a 15-inch LCD monitor, keyboard, mouse and Nivio companion (which enables the PC to connect to a backend Linux-run server for storage and applications) and priced at Rs 7,999 exclusively for Airtel broadband customers.

Available at Airtel Stores & NEXT Electronic Stores from tomorrow -

It will initially be available at Airtel Stores and NEXT Electronic Stores in Delhi, Gurgaon and Noida from tomorrow. If customers do not want the monitor, the package costs Rs 4,999.

A next-generation computer that never goes obsolete and never crashes

• 10 GB data storage space from Nivio, original and latest software from Microsoft with every Net PC
• Ready-to-use online computer complete with 15” LCD monitor, Keyboard, Mouse and Nivio Companion
• Available at Airtel Stores and NEXT Electronic Stores in Delhi, Gurgaon and Noida

Source: Airtel

Tiger Airways Asia-Pacific's low fare airline

Tiger Airways is Asia-Pacific's true low fare airline.

About it

Tiger Airways took to the skies from Singapore in September 2004 with two aircraft in its fleet and three routes in its network. Within four years of operation, Tiger Airways operates from its Singapore and Melbourne bases, with a third base in Adelaide to commence operations in early 2009. Tiger Airways now flies to more than 25 destinations across 9 countries in Asia and Australia on a fleet of brand new Airbus A320 aircraft.

Source: Tiger Airways

Tax exemption limit may go up

Budget May Hike It To Rs 1.75-Rs 2L From Rs 1.5L, FBT Could Go Up

The full budget to be presented by the new government in the forthcoming session of Parliament to begin sometime next month may come packed with some concessions for the middle class by way of raising the tax exemption limit to up to Rs 1.75-Rs 2 lakh from the current Rs 1.50 lakh.

Other Benefit

The other benefit in the direct tax segments could be withdrawal of the Fringe Benefit Tax [FBT].

If through, both these measures will result in a tax outgo of around Rs 10,000 crore. Proposals in this regard are under active consideration, indicated a senior official in the finance ministry.

Other Proposals

The commerce ministry is firmly backing industry’s proposals for extending tax sops to export-oriented units, besides the continuation of interest rate subvention till March 2010.

In their proposals to the finance ministry, industry chambers had asked the government to include measures in the budget that would promote investment and create additional demand.

Japanese PAL – JPAL webinar/training

Check out for upcoming Pharmaceutical Affairs Law training will go into the unique challenges facing the Foreign Manufacturer when working with the Japanese.

1. Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers
2. International GMP’s for Medical Devices: Quality System requirements for USA, Europe, Canada and Japan
3. GCP Audit of Clinical Evaluations for Japan: Requirements and expectations from the revised Japanese PAL

Source: ComplianceOnline

Water system compliance training/webinar

Check out upcoming list of Water system compliance training/webinar focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches.

1. Water System Compliance - Successful Sanitization Approaches for Trouble-Free Water Quality
2. Water System Compliance - What Makes Water Systems Have Microbial Quality Problems
3. Water System Compliance - Harmonizing Water Microbial Testing for Optimal Quality Control
4. Water System Compliance - Understanding and Controlling Endotoxin
5. Water System Compliance - Implementing Changes to a Validated System

Source: ComlianceOnline

HP to lay off 6,400 employees more

Hewlett-Packard Co gave a disappointing outlook for full-year revenue and said it will lay off another 2 per cent of its workforce as consumers and businesses cut spending on computers, printers and services, sending its shares down about 5 per cent.

The mew round of layoffs - which total roughly 6,400 jobs - announced on Tuesday are on top of previously announced cuts from integrating the operations of IT services company EDS, which HP acquired last year.

HP said the job cuts will come in its product segments, such as PCs and printers. The reductions will happen over the next 12 months.

HP, which vies with smaller rivals Dell Inc and Acer Inc in a depressed global PC market, also expects fiscal year revenue to slide 4 per cent to 5 per cent compared with a previously forecast of 2 per cent to 5 per cent, offering a more pessimistic view of 2009