Thursday, September 24, 2015

WHO Training Guide To GMPs - FREE

This is a wonderful free resource for those involved in or responsible for delivering GMP training or classroom sessions. The World Health Organization (WHO) published this guide, so that it could "help both trainers and supervisors solve some of the problems they face involving training, such as how to make the training interesting to adult learners or how to effectively use a variety of instructional methods."

A WHO Guide To Good Manufacturing Practice (GMP) Requirements, Part 3: Training (PDF), is organized by the following major chapters:
  1. Introduction and purpose of this guide
  2. The importance of training
  3. Types of training and content areas
  4. Developing and implementing training
  5. Assessment and evaluation
  6. Administrating a training programme
  7. Questionnaire
#FDA #cGMP #GMP #training #WHO

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Friday, September 18, 2015

The Fake Drug Industry Is Exploding, and We Can’t Do Anything About It - Newsweek

Read this enlightening article: The Fake Drug Industry Is Exploding, and We Can’t Do Anything About It - Newsweek:

. . ."many experts believe that the problem is on the rise and that more criminals are turning to pharmaceuticals for a simple reason: low risk and high reward. “The penalties are relatively weak for trading in falsified pharmaceuticals compared to those for trade in narcotics and human trafficking,” says Paul Newton, a professor of tropical medicine at the University of Oxford medical school who has spent decades tracking poor-quality medicines. And criminals can make a lot of money by falsifying drugs that are in high demand, in short supply or are exorbitantly expensive for consumers."

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Thursday, September 17, 2015

Robert Califf Could Transform The FDA -- The Right Way - Forbes

Read the full article: Robert Califf Could Transform The FDA -- The Right Way - Forbes:

"People who care about making sure that medicines and medical devices are safe and effective should be cheering the nomination of Robert Califf to be the new commissioner of the Food and Drug Administration, and any senators who slow his path to the job he deserves should be accused of practicing the basest kind of partisanship."

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Wednesday, September 16, 2015

Obama to Nominate Robert Califf to Lead FDA - WSJ

Read the full article: Obama to Nominate Robert Califf to Lead FDA - WSJ:

"President Barack Obama plans to nominate the prominent cardiologist and medical researcher Robert Califf as the next commissioner of the Food and Drug Administration, the White House said Tuesday.

Dr. Califf had been named the FDA’s deputy commissioner for medical products and tobacco—effectively the No. 2 post—in February. He joined the FDA from Duke University, where he had served as a professor of medicine, a leading pharmaceutical researcher and the vice chancellor for clinical and translational research."

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