Be Careful What You Wish For: Specialized FDA Inspectors Don’t Necessarily Mean Happier Inspections - FDA Law Blog

Read the entire article: FDA Law Blog: Be Careful What You Wish For: Specialized FDA Inspectors Don’t Necessarily Mean Happier Inspections:

"Such specialized investigators may be more adept and knowledgeable at identifying issues, making for undoubtedly “smoother inspections” instead of flailing around.  But just because an inspection may be smoother, it does not mean that there will be happier consequences for the affected facilities."

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#FDA #cGMP #GMP #training #courses #classes

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GMP Training | Live - Onsite - In-Person by ...

Allan Dewes - SkillsPlus Intl Inc.

Updated July 16, 2020

The entire world is having to adjust to COVID-19.

If you're finding it difficult to arrange live training, then you'll be interested in online FDA cGMP QSR GMP training courses taught by us, SkillsPlus International Inc;

• FDA GMP QSR cGMP Online Training Courses - presented by SkillsPlus International Inc.

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cGMP Training | Live - Onsite - In-Person by Allan Dewes, SkillsPlus International Inc.

Explore SkillsPlus Intl Inc. onsite courses that master trainer, Allan Dewes, can teach in-plant, at your site. We always tailor our courses to suit your site's learning needs and environment.

SkillsPlus GMP training is engaging, energetic, and enlightening.

Here's a small sample of what our students have to say ...

Learn more:  SkillsPlus Intl Inc. - FDA QSR GMP Training On-Site Course Catalog (PDF)

#FDA #cGMP #GMP #training #courses #classes

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FDA will destroy banned imported drugs - Modern Healthcare

• Trusted FDA CGMP online training courses sold by SkillsPlus International Inc.

Updated June 16, 2025

The original link broke.

You can still read about this same topic on this FDA webpage:

https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-imports

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Read the full article: FDA will destroy banned imported drugs - Modern Healthcare Modern Healthcare business news, research, data and events:

"Federal regulators will begin destroying some medications that can't be imported into the U.S.​ because of quality concerns.

Beginning Oct. 15, the U.S. Food and Drug Administration will destroy a drug that wasn't allowed into the U.S. because it's been found to have been “adulterated, misbranded or unapproved” and in violation of the Food, Drug and Cosmetic Act. The policy covers a drug if the value of a single dose is $2,500 or less. "

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WHO Training Guide To GMPs - FREE

• People also search for Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses - GMP online training classes offered by SkillsPlus International Inc.

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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The Government Really Means It This Time - FDA Law Blog

• Trusted FDA GMP online training programs and classes offered by SkillsPlus International Inc.

Read the full article: FDA Law Blog: The Government Really Means It This Time:

"In the last year alone, several high-level government officials have repeated the clear message that responsible corporate officers are in the crosshairs of DOJ and FDA in both misdemeanor and felony situations."

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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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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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Obama to Nominate Robert Califf to Lead FDA - WSJ

• FDA GMP QSR cGMP Training - highly recommended online training courses by SkillsPlus International Inc.

Updated December 3, 2020

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As Nation Awaits Vaccine, Biden Is Under Pressure to Name New FDA Chief ASAP - KHN

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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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In a first, drug using 3D printing technology gets FDA nod | Reuters

Read the full article: In a first, drug using 3D printing technology gets FDA nod | Reuters:

"The U.S. Food and Drug Administration has, for the first time, approved a drug that uses 3D printing technology, paving the way for potential customization of drugs to suit patients' needs.

The drug, made by privately held Aprecia Pharmaceuticals Co, was approved for oral use as a prescription adjunctive therapy in the treatment of epilepsy, the company said on Monday."

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Request for Quality Metrics - FDA Guidance for Industry

The FDA has released a guidance document that includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to collect data and use quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry.

Read the guidance:  FDA Request for QualityMetrics - Guidance for Industry (PDF)

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