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).

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

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.

Source: Rediff

Upcoming Pharma and biotech webinars/training

Check Pharma 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.

Source: ComplianceOnline

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

Japanese PAL – JPAL webinar

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: ComplianceOnline

Ways to Search for a Predicate Device

The FDA 510(k) database contains all devices cleared under the 510(k) process. The FDA databases on the web are updated on or around the 5th of every month. The classification of the device and product code is essential in searching for predicate devices. Classification of your device can be found by performing a search on the Product Code Classification Database.

Information which can be useful to find a predicate device includes:

• names of similar devices – traded name under which the device is marketed;
• manufacturer(s) of the similar device(s);
• marketing status, i.e., preamendments or postamendments device;
• 510(k) numbers for postamendments devices;
• classification information, i.e., product codes, classifying regulations, etc., for your device.

Source: FDA

About Predicate Device (Medical Device)

A Premarket Notification [510(k)] is a premarketing submission made to FDA to demonstrate that the device to be marketed is safe and effective by proving substantial equivalence (SE) to a legally marketed device (predicate device) that is not subject to Premarket Approval (PMA). Submitters must compare their 510(k) device to a similar legally marketed U.S. device(s). A device recently cleared under 510(k) is usually used as a predicate device.

The legally marketed device(s) to which equivalence is drawn is known as the predicate device(s).

A claim of substantial equivalence does not mean the device(s) must be identical.Substantial equivalence is established with respect to: intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics. You can claim SE to either a preamendments or postamendments device that is or was legally marketed. Legally marketed means that the predicate cannot be one that is or was in violation of the Federal Food Drug & Cosmetic (FD&C) Act. An applicant may claim SE to a device that is no longer being marketed in the U.S.

Source: FDA