Monday, November 28, 2011

What is GMP?

What is GMP?:

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Wednesday, November 23, 2011

Electronic Orange Book Online - It'll be a wait for the 2012 version

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

Electronic Orange Book Online | The Health, Drug, Prescription, and GMP Supersite:  'via Blog this'

OK you eager beavers out there!   If history serves us, you'll have to wait until the end of Q1 2012 to see a brand new cumulative version of the Orange Book that is current through the end of 2011.

In the meantime, just navigate to the link provided above for your needs.

Happy hunting, and be patient!

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Tuesday, November 22, 2011

FDA Consumer Updates - Food Safety Tips for Healthy Holidays

FDA Consumer Updates; Food Safety Tips for Healthy Holidays:


"Parties, family dinners, and other gatherings where food is served are all part of the holiday cheer. But the merriment can change to misery if food makes you or others ill.

Typical symptoms of foodborne illness are vomiting, diarrhea, and flu-like symptoms, which can start anywhere from hours to days after contaminated food or drinks are consumed.

The symptoms usually are not long-lasting in healthy people—a few hours or a few days—and usually go away without medical treatment. But foodborne illness can be severe and even life-threatening to anyone, especially those most at risk:
- older adults
- infants and young children
- pregnant women
- people with HIV/AIDS, cancer, or any condition that weakens their immune system
- people who take medicines that suppress the immune system; for example, some medicines for rheumatoid arthritis

Combating bacteria, viruses, parasites, and other contaminants in our food supply is a high priority for the Food and Drug Administration. But consumers have a role to play, too, especially when it comes to safe food-handling practices in the home."

'via Blog this'
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FDA.gov Free Title 21 CFR Search Tool

Code of Federal Regulations, seen at the Mid-M...
Image via Wikipedia
CFR - Code of Federal Regulations Title 21:   'via Blog this'

The FDA.gov website makes this free search tool available.

It helps you to search within CFR - Code of Federal Regulations Title 21 - Food and Drugs: Parts 1 to 1499

Nice little search page.

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Monday, November 21, 2011

An Alternative To The Free Online GCP Training by Quintiles

Updated 4/10/2015:
The Quintiles GCP training is no longer available to the public for free.
I recently discovered a free, publicly accessible GCP training program that might be of interest to you: The Good Clinical Practice (GCP) course, offered by the National Drug Abuse Treatment Clinical Trials Network

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!














= = =

Free Online GCP Training | Clinical Research Learning Blog:  'via Blog this'
Upon completion of the program the participant will be able to:
  1. Describe the ICH Good Clinical Practice (GCP) and local regulatory guidelines for good clinical practice in the conduct of clinical trials 
  2. Discuss the investigator’s responsibilities in the conduct of clinical trials at the clinical site 
  3. Apply ICH and local regulations to specific research activities at the clinical site
Free is good!

Quintiles helps pharmaceutical, biotechnology and medical device companies develop and market innovative therapies. Quintiles is also a full sized CRO and has its operations over more than 40 countries world wide.  

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SkillsPlus Intl Info Blog

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The Exemptee Institute
The Designated Representative Institute

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Saturday, November 19, 2011

FDA withdraws approval of drug Avastin to treat breast cancer

FDA withdraws approval of drug Avastin to treat breast cancer - latimes.com:

"Studies showed that women with advanced breast cancer taking Avastin had a higher risk of death from stroke or heart attack, and that the medication raised blood pressure and increased the risk of congestive heart failure. The risk of serious bleeding was five times higher among users of Avastin than it was for those on chemotherapy only."  'via Blog this'
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Wednesday, November 16, 2011

FDA CDRH Learn - CDRH Learn Spanish Language Course List

FDA CDRH Learn; CDRH Learn Course List (Spanish):    'via Blog this'

The FDA CDRH offers the following courses in Spanish:
According to Wikipedia's Languages of the United States, approximately 10% of the US population speaks Spanish.

Hope you find these free FDA resources helpful.

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Tuesday, November 15, 2011

FDA Inspection Classification Database Search - Free

FDA Inspection Classification Database Search:   'via Blog this'

Wow! The FDA is disclosing inspection information to help improve the public’s understanding of how the FDA works to protect the public health. Disclosure of the compliance status of firms helps to provide the public with a rationale for the Agency’s enforcement actions and will also help to inform public and industry decision-making, allowing them to make more informed marketplace choices and help to encourage compliance.

In this inspections database, the FDA is specifically disclosing the final inspection classification for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed.

Have a go at it!

You might be interested in:
Inspection Detection - an FDA cGMP training aid or game, focusing on 483 citations 

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.
This class prepares plant personnel to participate in an FDA Inspection.
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Monday, November 14, 2011

Seven Strategies for Avoiding a 483

Updated January 18, 2017

The link in the original post broke.

You might also be interested in:
In-Person Ways to Avoid Form 483 Observations and Warning Letters - MDDI

- -  original post follows below  - -

Seven Strategies for Avoiding a 483:  'via Blog this'

"What a 483 is — and isn’t. After inspecting a food, drug, medical device, or biologic establishment, FDA prepares a written report of its inspection findings, following a debriefing. This report is intended primarily for internal FDA use and is not provided to the inspected institution at the conclusion of the on-site visit."
A nice, quick and easy primer on 483s.

You might also be interested in:
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FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
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Free GMP Training Tips

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Wednesday, November 9, 2011

Fatty Foods Addictive as Cocaine

Nora Volkow, director of the National Institut...Image via WikipediaFatty Foods Addictive as Cocaine in Growing Body of Science - Businessweek:  'via Blog this'

“The data is so overwhelming the field has to accept it,” said Nora Volkow, director of the National Institute on Drug Abuse. “We are finding tremendous overlap between drugs in the brain and food in the brain.”
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Tuesday, November 8, 2011

FDA Approves New Device - Screens for Melanoma

Title: Pathology: Patient: Melanoma: Asymmetry...
Image via Wikipedia
Updated 9/6/2013:
The original AP link below is broken. So here's a link to a similar article:
http://usatoday30.usatoday.com/news/health/story/2011-11-02/New-device-uses-light-to-screen-for-melanoma-detect-earlier/51040310/1

- - - - -

The Associated Press: New device uses light to screen for melanoma:    'via Blog this'

"The Food and Drug Administration (FDA) approved a first-of-its-kind device, called MelaFind, that makes detailed, digital images of skin growths and uses a computer to analyze them for signs of cancer, offering a sort of second opinion to doctors. The device is approved only for dermatologists and only for use on growths that don't have obvious signs of cancer but still have one or two worrisome traits."

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Monday, November 7, 2011

4 Health Behaviors 4 Longer Life - some alcohol

CDC Features - Four Specific Health Behaviors Contribute to a Longer Life: 'via Blog this'

To live healthier and longer, drink "some."  The key is "Drink alcohol in moderation (men should have no more than two drinks per day; and women no more than one drink per day)."

For more information:


GMP QSR Posters by SkillsPlus Intl Inc.
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Saturday, November 5, 2011

Nizoral Shampoo Available Again - I'm thrilled!

Woo-hoo!  After a very long wait, Nizoral Shampoo is back on store shelves.



The manufacturer has been is blaming a switch in manufacturing facilities.

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.
This class prepares plant personnel to participate in an FDA Inspection.
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

GMP Posters by SkillsPlus Intl Inc.
SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 
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Thursday, November 3, 2011

FDA Awards Two New Regulatory Research Centers

Photograph of the Taxus drug-eluting stent, fr...Image via WikipediaFDA launches two centers to improve approval of drugs, devices - The Hill's Healthwatch:  'via Blog this'

"The Food and Drug Administration (FDA) on Wednesday awarded $2 million to support the creation of research centers tasked with improving the way new medicines and medical devices are reviewed and evaluated."

The centers will be established at the University of Maryland and Georgetown University.

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Wednesday, November 2, 2011

FDA Awards University Consortium To Improve Drug Manufacturing

Drug shortages: University of Maryland, other universities work to improve drug manufacturing process - baltimoresun.com:   'via Blog this'

The Food and Drug Administration (FDA) has given "a $35 million grant to" the National Institute for Pharmaceutical Technology and Education, a group of 11 universities, "to make the nation's drugs safer and less costly, and even produce more jobs, by improving the science of manufacturing."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!














SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Who Offers Live Onsite GMP Training?
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

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