FDA Issues Final Regulation on Dental Amalgam

July 30, 2009

The regulation classifies dental amalgam into Class II (moderate risk). By classifying a device into Class II, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of the device.

Specifically, the FDA recommended that the product labeling include:

  • A warning against the use of dental amalgam in patients with mercury allergy;
  • A warning that dental professionals use adequate ventilation when handling dental amalgam;
  • A statement discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor. The statement will help dentists and patients make informed decisions about the use of dental amalgam.

Source: FDA

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Kargil war lets remember our hero’s

July 26, 2009

kargil-war-war-against-terror1The Kargil War, was an armed conflict between India and Pakistan that took place between May and July 1999 in the Kargil district of Kashmir.

The cause of the war was the infiltration of Pakistani soldiers and Kashmiri militants into positions on the Indian side of the Line of Control (LOC), which serves as the de facto border between the two states.

During and directly after the war, Pakistan blamed the fighting entirely on independent Kashmiri insurgents, but documents left behind by casualties and later statements by Pakistan’s Prime Minister and Chief of Army Staff showed involvement of Pakistani paramilitary forces, led by General Ashraf Rashid.

The Indian Army, later on supported by the Indian Air Force, attacked the Pakistani positions and, with international diplomatic support, eventually forced withdrawal of the Pakistani forces across the LOC.

http://en.wikipedia.org/wiki/Kargil_War


10 years of kargil war lets pay tribute to our Hero’s

July 26, 2009

kargil-war-war-against-terror1Lets pay tribute to our Kargil Hero’s


Medical Device Webinars / trainings @$149 (On-Demand)

July 23, 2009

Are you looking for online training for Medical Device Industries and Life Sciences?  What all it has –

  • 60 minutes of online training
  • Convenient access anytime, anywhere
  • A great way to meet your educational needs
  • Courses for the Life Sciences and Medical Device Industries

Check out here –

  1. Basic Requirements for Steam Sterilizer Validation per ISO 17665
  2. Best Practices for Managing FDA Investigators and Handling FDA 483 Observations
  3. Medical Device Complaints, MDR’s and Recalls
  4. Six Sigma Methodology for Process Validation
  5. Documenting a Risk-Based Quality System – for Compliance and Cost-Savings
  6. How to perform effective supplier audits, and avoid FDA 483’s and Warning letters
  7. Verification vs. Validation in Regulated Industries
  8. CAPA Essentials – core principles and practices needed to implement an effective and efficient CAPA process
  9. Introduction to Process Capability (Cp, CpK, Pp, Ppk)
  10. How to Use the System Risk Level to Save Time and Money on Computer System Validations
  11. Implementing the new International and FDA accepted Software Development Standard IEC 62304
  12. Risk Management Activities during Design Input
  13. Developing a Robust CAPA System
  14. Complying with 21CFR Part 11-Understanding the Role of Predicate Rules
  15. The New Dietary Supplement Good Manufacturing Practices
  16. Configuration Management and Change Control for Computer Systems
  17. Cleanroom Operation, Maintenance and Operators
  18. Conducting and Documenting Proper Risk Analysis In compliance with ISO 14971
  19. 510(k) Preparation for a Small to Medium-Sized Company
  20. Applying Lean Documents to a Project – how to create a project file, follow design controls, yet maintain a lean set of project documents.

Planning to buy home? Look what you need to know

July 15, 2009

Well it all starts from

  1. Searching Home
  2. Check the payment mode which you want
  3. Look into Developer agreement
  4. Have close eye on Property dealers
  5. Choose the right bank/HFC (housing finance company)
  6. Once you buy then

Ways of Searching Home

  1. Start looking into advertisements in local newspapers
  2. Better to approach the bank or the HFC as they already have list of pre approved builders / developers listed.

Check the payment mode which you want

Choose from the 2 available payment modes

  1. A lumpsum upfront payment when you choose this you have chance of getting 5-10% discount (But I would said not to opt this one)
  2. One that is construction-linked – best option to go with

Look into Developer agreement

Check for

  1. Exit clause
  2. Approved building plan are made a part of the agreement

Have close eye on Property dealers

  1. Don’t belive them blindly
  2. Check creditibility before you select

Choose the right bank/HFC (housing finance company)

Look at its response to interest rate movements. Look at how it revised its rates during the boom period. Choose an institution that is proactive in changing its home loan rates when interest rates move up or down.

From December 2009 you will have access to your credit score. Use a good credit score to get a better rate of interest on your loan.

Once you buy then

  1. Regularly visit the construction site to check the progress
  2. Get in touch with others invested in the project.

Check rediff to know more

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e-Filing Process (TAX)

July 13, 2009

E-Filing Tax

  1. Select appropriate type of Return Form
  2. Download Return Preparation Software for selected Return Form
  3. Fill your return offline and generate a XML file.
  4. Register and create a user id/password
  5. Login and click on relevant form on left panel and select “Submit Return”
  6. Browse to select XML file and click on “Upload” button
  7. On successful upload acknowledgement details would be displayed. Click on “Print” to generate printout of acknowledgement/ITR-V Form.

Click here to know more

Source: Income Tax Department, India.

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Stuck in debt & don’t know how to cope up

July 8, 2009
  1. Try to lower your interest rate. Negotiate with your bank. One other way is to convert your credit card debt into a personal loan debt. It will definitely be lesser than the credit card interest rate.
  2. Calculate your net worth and see if any of your investments could help you prepay a part of your loans.
  3. Make a contingency plan for the immediate future. Talk to your bank along with your debt counselors and explain your situation and see if you can resume your loan at a later date but do make an effort to prepay some amount.
  4. If it is a double-income household, try and see if your spouse can support you in the event of a job-loss in the short term before you land a job.
  5. Manage your current finances judiciously to battle through the current situation and emerge wiser.

Source: BankBazaar.com

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