Wednesday, November 19, 2014

CRN FDA GMP Warning Letter Database - For Dietary Supplements - Free

Read the full press release: CRN FDA GMP Warning Letter Database Document:

"The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, today announced a free online tool that compiles FDA Warning Letters sent to dietary supplement companies into a searchable database to help industry achieve better regulatory compliance. The database can be used to evaluate FDA’s warning letter allegations of good manufacturing practices (GMPs) violations, products making impermissible claims, and products tainted with illegal ingredients."

'via Blog this'

Access the CRN FDA Warning Letters Database for Dietary Supplements

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

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


Tuesday, November 18, 2014

FDA - Consumer Updates > Food Safety Tips for Healthy Holidays

Read the full article: Consumer Updates > Food Safety Tips for Healthy Holidays - FDA.gov:

"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.

"The good news is that practicing four basic food safety measures can help prevent foodborne illness," says Marjorie Davidson, a consumer educator at FDA."

'via Blog this'

Additional links:

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

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

Monday, November 17, 2014

Great American Smokeout - Thurs Nov 20 | American Cancer Society

Learn more:  Great American Smokeout | American Cancer Society:

"The American Cancer Society marks the Great American Smokeout on the third Thursday of November each year by encouraging smokers to use the date to make a plan to quit, or to plan in advance and quit smoking that day. By quitting — even for one day — smokers will be taking an important step towards a healthier life – one that can lead to reducing cancer risk."

'via Blog this'

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

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


Friday, November 14, 2014

Best Practices for Handling FDA Inspections - Pharmaceutical Compliance Monitor

Read the full article: Best Practices for Handling FDA Inspections - Pharmaceutical Compliance Monitor:

"Successfully managing an FDA inspection begins with the development of a clear company policy. It requires frequent employee training so they are in a position to maintain best practices regarding day-to-day procedures. Companies also need to make sure they define the roles and responsibilities of all company employees during an inspection.

Based on 15 years of experience and eight successful FDA inspections, here are some best practices to prepare for a successful FDA Inspection."

'via Blog this'

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

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


Thursday, November 13, 2014

Hospital Workers Wash Hands Less at End of Shift, Study Finds - HealthDay

Read the full article: Hospital Workers Wash Hands Less at End of Shift, Study Finds - HealthDay:

"Health workers in hospitals wash their hands less often as they near the end of their shift, a new study has found.

And this lapse -- likely due to mental fatigue -- could contribute to hundreds of thousands of patient infections a year in the United States, the researchers noted."

'via Blog this'

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

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


Tuesday, November 11, 2014

Trouble Swallowing Pills? Here’s 2 Ways to do it Right - American News

Read the full article for more details: Trouble Swallowing Pills? Here’s 2 Ways to do it Right - American News:

"“In conclusion, this study showed for the first time that two targeted techniques to facilitate tablet and capsule intake were remarkably effective and easy to adopt in the general population including patients with swallowing difficulties, and should therefore be generally recommended,” the study authors write."

'via Blog this'

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

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


Doctors Cash In on Drug Tests for Seniors, and Medicare Pays the Bill - WSJ - WSJ

Read the full article: Doctors Cash In on Drug Tests for Seniors, and Medicare Pays the Bill - WSJ - WSJ:

"Doctors are testing seniors for drugs such as heroin, cocaine and “angel dust” at soaring rates, and Medicare is paying the bill.

It is a roundabout result of the war on pain-pill addiction.

Medical guidelines encourage doctors who treat pain to test their patients, to make sure they are neither abusing pills nor failing to take them, possibly to sell them.

Now, some pain doctors are making more from testing than from treating."

'via Blog this'

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

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

Wednesday, November 5, 2014

GMP News: Statistical Analysis of FDA's Inspection Findings

Follow this link to view the graph: GMP News: Statistical Analysis of FDA's Inspection Findings:

"The observation summary counts more than 5.000 483 Forms - including in addition to drugs also further fields like foods which have been analysed separately.

Another interesting summary is the webpage with FAQs relating to the 483 Form.

The following graph shows an analysis of the 483 identified during fiscal year 2013." . . .

'via Blog this'

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

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


FDA: Consumer Updates > Mixing Medications and Dietary Supplements Can Endanger Your Health

Read the full article: FDA - Consumer Updates > Mixing Medications and Dietary Supplements Can Endanger Your Health:

"What is FDA’s Role?

Although FDA has oversight of the dietary supplement industry, it is the supplement manufacturers and distributors that are responsible for making sure their products are safe before they’re marketed. Manufacturers are required to produce dietary supplements that meet minimum quality standards, do not contain contaminants or impurities, and are accurately labeled.

FDA does not review supplements for effectiveness (as it does for prescription and OTC medications) before they enter the market. If the dietary supplement contains a new dietary ingredient, the manufacturer must submit for FDA’s review data on that ingredient’s safety—but not its effectiveness.

FDA takes enforcement actions against manufacturers if their products are found to be unsafe, adulterated and/or misbranded (for example, if their labeling is false or misleading) or if products marketed as dietary supplements are making claims to diagnose, mitigate, treat, cure, or prevent a disease."

'via Blog this'

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

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


Friday, October 3, 2014

2014 Ebola Outbreak in West Africa - FDA.gov

Read the full FDA article: Medical Countermeasures Initiative > 2014 Ebola Outbreak in West Africa - FDA.gov:

"Fast Facts 
  • Ebola is the cause of a viral hemorrhagic fever disease.
  • Currently, there are no FDA-approved vaccines or drugs to prevent or treat Ebola.
  • Ebola does not pose a significant risk to the U.S. public.
Treatment:
CDC recommends supportive therapy for patients as the primary treatment for Ebola. This includes balancing the patient’s fluids and electrolytes, maintaining their oxygen status and blood pressure and treating them for any complicating infections."

'via Blog this'

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

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


Tuesday, September 23, 2014

What You Should Know for the 2014-2015 Influenza Season | Seasonal Influenza (Flu) | CDC

Read the full fact page: What You Should Know for the 2014-2015 Influenza Season | Seasonal Influenza (Flu) | CDC:

"People should begin getting vaccinated soon after flu vaccine becomes available, ideally by October, to ensure that as many people as possible are protected before flu season begins."

'via Blog this'

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

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


Monday, September 22, 2014

Five Steps That Men Can Take to Avert a Heart Attack - NBC News.com

Read the full article: Five Steps That Men Can Take to Avert a Heart Attack - NBC News.com:

"Men who take just five healthy steps can reduce their odds of a heart attack by four-fifths, but just 1 percent of men do so on their own, according to new research published Monday. The steps are nothing secret: They are not smoking, drinking moderately, exercising daily, eating a healthy diet and keeping the belly in check."

'via Blog this'

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

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


Saturday, September 20, 2014

FDA to Middle-Aged Men: You Probably Don’t Need Testosterone Therapy - MensJournal.com

Read the full article: FDA to Middle-Aged Men: You Probably Don’t Need Testosterone Therapy - MensJournal.com:

" A recent study found that testosterone therapies doubled the heart attack risk for men over age 65 and for younger men with a history of heart disease after only three months of use. And in June the FDA began requiring drug manufacturers to include a warning label on product packaging, stating that these treatments may cause blood clots.

Schwartz says they may also increase PSA levels, an indicator of prostate cancer risk, although they haven’t been proven to increase the risk. “Given these potential harms and the fact that these are unproven therapies for men with low T of aging,” she says, “what’s going on right now is a huge uncontrolled experiment.”"

'via Blog this'

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

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


Friday, September 12, 2014

Hallucinogen in 'magic mushrooms' helps longtime smokers quit in Hopkins trial | Hub

Read the full article: Hallucinogen in 'magic mushrooms' helps longtime smokers quit in Hopkins trial | Hub:

"Johns Hopkins researchers report that a small number of longtime smokers who had failed many attempts to drop the habit did so after a carefully controlled and monitored use of psilocybin—the active hallucinogenic agent in so-called "magic mushrooms"—in the context of a cognitive behavioral therapy treatment program.

The abstinence rate for study participants was 80 percent after six months, much higher than typical success rates in smoking cessation trials, says Matthew W. Johnson, an associate professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine, and the corresponding author on the study."

'via Blog this'

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
cGMP Mini-Series - Short Videos for GMP Trainer Use
SkillsPlus Intl Info Blog

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


Custom Search

From SkillsPlus International Inc.

Custom Search

Even More Resources, Books, & Things (many from Amazon.com)

FDA, GMPs, QSR, GCP, GLP, GXP:
21 CFR Parts 210 and 211: Drug Industry GMP's     Compact Regs Parts 807, 812, and 814: CFR 21 Parts 807, 812, and 814 Medical Device Approval (10 Pack)     The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices     Compact Regs Part 11: CFR 21 Part 11 Electronic Records; Electronic Signatures (10 Pack)     How to Fail an Fda Quality Audit: A Look at Some of the Causes of Failure to Comply With Fda Quality Regulations     Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance     How to Develop and Manage Qualification Protocols for FDA Compliance         Agent GXP FDA Part 11 Guidebook: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... Trials and GCP (Good Clinical Practices)     Development of Fda-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices     FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics     Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics)     Clinical Studies Management: A Practical Guide to Success     Analytical Chemistry in a GMP Environment: A Practical Guide     Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Biotechnology and Bioprocessing Series)     Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook     Preclinical Drug Development (Drugs and the Pharmaceutical Sciences)     Group Sequential Methods: Applications to Clinical Trials (Chapman & Hall/Crc Interdisciplinary Statistics Series)     Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition     Pharmaceutical Stress Testing: Predicting Drug Degradation (Drugs and the Pharmaceutical Sciences)     Cleaning Validation: A Practical Approach     Validated Cleaning Technologies for Pharmaceutical Manufacturing     Risk-Based Compliance Handbook     Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume I (1)     Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded (Volume 2)     Bioprocess Validation: The Present and Future     Laboratory Validation: A Practitioner's Guide     Quality Assurance Workbook for Pharmaceutical Manufacturers     Risk-based Software Validation: Ten Easy Steps     ISO 13485 and FDA QSR Internal Audit Checklist     ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms
Training Resources:
1001 Ways to Reward Employees     Planning Programs for Adult Learners: A Practical Guide for Educators, Trainers, and Staff Developers, 2nd Edition     50 Creative Training Openers and Energizers     Personalized M&M Candies     Oriental Trading Co - Training toys and supplies     GMP Training Gifts & Giveaways     GMP Training & Quality Posters