Water system compliance training/webinar

May 20, 2009

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

May 15, 2009

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)

May 15, 2009

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



Trace Mobile phone location & Service Provider Details

May 14, 2009

Here is great site to Trace Mobile phone location & Service Provider Details- Click here

or visit this page- : http://www.hacktrix.com/trace-mobile-phone-location-and-service-provider-details/index.php


Biggest surprise of Election 2009?

May 14, 2009

Exit Polls- 2009 Lok Sabha Election

May 14, 2009

Highlights

  • Bihar sees a clean sweep for JDU-BJP Alliance
  • Congress retains dominance in Andhra Pradesh
  • Split in BJP-BJD Alliance, lets Congress through in Orissa
  • Decisive win for BJP in Gujarat
  • Uneven vote distribution results in convincing victory for BJP in Karnataka
  • Neck-and-neck between AIADMK and DMK Front in Tamil Nadu

Alliances Details

NDA: BJP, JDU, SS, AFP, AKALI, RLD, INLD, NPF
UPA: CONG, NCP, DMK, TC, JMM, JKNC, RPI
3rd Front: LEFT, BSP, AIADMK, TDP, BJD, TRS, PMK, JDS,MDMK
4th Front: RJD, LJP, SP, PRP

Exit Poll

Source: NDTV


What Is a Clinical Trial?

May 13, 2009

What Is a Clinical Trial?

Clinical trials are research studies in which people help doctors find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer.

Why are there clinical trials?

A clinical trial is one of the final stages of a long and careful cancer research process. Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective.

What are the different types of clinical trials?

Treatment trials test new treatments (like a new cancer drug, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy).

Prevention trials test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer.

Screening trials test the best way to find cancer, especially in its early stages.

What are the phases of clinical trials?

Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Most clinical trials are classified into one of three phases:

* Phase I trials:

These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.

* Phase II trials:

A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.

* Phase III trials:

These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors’ offices, clinics, and cancer centers nationwide.

Source: National Cancer Institute