Saturday, January 31, 2015

Buzz Kill: 3 Daily Cocktails May Boost Stroke Risk: Study - NBC News.com

Read the full article: Buzz Kill: 3 Daily Cocktails May Boost Stroke Risk: Study - NBC News.com:

"People in their 50s and 60s who down more than two alcoholic beverages daily have a 34 percent higher risk of stroke compared to lighter drinkers — and are more apt to suffer a stroke five years earlier in life regardless of their genetics or their other health habits, asserts a study released Thursday."

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Wednesday, January 7, 2015

'Fat but Fit' Only Temporary | Medpage Today

Read the full article: 'Fat but Fit' Only Temporary | Medpage Today:

"David Katz, MD, of Yale's Prevention Research Center, told MedPage Today that the concept of metabolically healthy obesity has "always generated more heat than light."

"Yes, it is better to be fat and fit than fat and unfit. And you can be thin and unfit. But in the real world, most people are either fit and lean, or fat and unfit," Katz said. "That's not a moral judgment -- it's because the very same lifestyle factors that make us fit tend to make us un-fat, and vice versa.""

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Tuesday, January 6, 2015

Guidances - A New & Better Way To Find FDA Guidance Documents

Go to a new search page for FDA: Guidances - FDA.gov:

" . . . all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

This feature is provided to give a convenient way to search for all FDA guidance documents from a single location. We will continue to refine it as we observe its performance."

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DASH named best overall diet for fifth year - report | Reuters

Read the full article: DASH named best overall diet for fifth year -report | Reuters:

"The DASH diet, rich in vegetables, whole grains and low-fat dairy, has been named the best overall diet for the fifth consecutive year, outpacing Weight Watchers and the Mediterranean diet, U.S. News & World Report said on Tuesday.

DASH, which was developed to lower blood pressure without medication, was also chosen by a panel of health experts as the top diabetes diet and the best plan for healthy eating."

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Sunday, January 4, 2015

Get Set for a Healthy Winter Season > FDA Consumer Updates

Read the full article for cold/flu prevention tips: Consumer Updates > Get Set for a Healthy Winter Season - FDA.gov: "

While contagious viruses are active year-round, fall and winter are when we're most vulnerable to them. This is due in large part to people spending more time indoors with others when the weather gets cold.

Fortunately, we can fight back with several FDA-approved medicines and vaccines."

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Wednesday, December 31, 2014

Flu season shaping up to be brutal - CNBC

Read the full article: Flu season shaping up to be brutal - CNBC:

"We're in the midst of what looks like a "very early and pretty aggressive flu season," according to Michael Smith, a doctor and chief medical editor for WebMD.

Flu season occurs during the colder months of the year and typically peaks between December and February, according to the Centers for Disease Control and Prevention."

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Tuesday, December 30, 2014

Traffic Stops Persuade People To Avoid Drinking And Driving : Shots - Health News : NPR

Read the full article: Traffic Stops Persuade People To Avoid Drinking And Driving : Shots - Health News : NPR:

"The study was published online in Alcoholism: Clinical and Experimental Research.

The same went for arrests for driving under the influence. The more DUI arrests, the fewer drunken drivers out on the roads.

In large part, Fell says, that's because word spreads quickly. When people know DUI laws are strictly enforced, "They think twice about drinking and driving." And when people see someone pulled to the side of the road by a cop, he adds, they'll likely consider their own speed and sobriety."

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Monday, December 22, 2014

FDA > Buy, Store & Serve Safe Food > Safe Food Handling: What You Need to Know

Read the full article: Buy, Store & Serve Safe Food > Safe Food Handling: What You Need to Know - FDA.gov:

"The Federal government estimates that there are about 48 million cases of foodborne illness annually – the equivalent of sickening 1 in 6 Americans each year. And each year these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths.

Since foodborne illness can be serious — or even fatal — it is important for you to know and practice safe food handling behaviors to help reduce your risk of accidentally getting sick from contaminated food."

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Happy Holidays: FDA Moves to Ban Cake, Donut 'Sprinkles' - Breitbart

Read the full article: Happy Holidays: FDA Moves to Ban Cake, Donut 'Sprinkles' - Breitbart:

"Although the amount of trans fats Americans consume has declined significantly in recent years, the FDA’s quest to completely eliminate a particular type of trans fat threatens to eliminate the noble “sprinkle,” used to decorate holiday treats and donuts. Even a small amount of joy is suspect in the FDA’s brave, new, food-monitored world."

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Friday, December 19, 2014

Healthcare Industry: The Top Target of Cyber Attacks - Pharmaceutical Compliance Monitor

Read the full article: Healthcare Industry: The Top Target of Cyber Attacks - Pharmaceutical Compliance Monitor:

". . . it might come as a surprise that most data breaches occurred within the medical/healthcare category. According to the Identity Theft Resource Center, 600+ breaches have taken place through October 2014—up nearly 26 percent from 2013. Healthcare providers and organizations account for approximately 42 percent of all breaches with 7.4 million personal records exposed this year alone.

Looking at these numbers it’s hard to argue against the vulnerability of any organization, regardless of their stature. Today, with advanced tools at hackers’ disposal, it’s truly not a matter of ‘if’ but ‘when’ a data breach will materialize."

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Thursday, December 18, 2014

Questionable Remedies for Eye Disease - NYTimes.com

RE: slowing the progression of macular degeneration and reducing the risk of vision loss

Read the full article: Questionable Remedies for Eye Disease - NYTimes.com:

"Some contained the right ingredients but not the right doses. Some added other stuff (selenium, B vitamins, grapeseed extract) that hasn’t been shown to slow macular degeneration and might actually reduce the effectiveness of the ingredients that do work. Of the 11 supplements that market research shows were top-sellers, only four duplicated the AREDS formula.

 Moreover, most manufacturers didn’t bother to point out that the AREDS results don’t pertain to everyone with macular degeneration, and that therefore some consumers won’t benefit from these products."

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Wednesday, December 17, 2014

Belly Fat Tied to Sudden Cardiac Death - NYTimes.com

Read the full article: Belly Fat Tied to Sudden Cardiac Death - NYTimes.com:

"As the researchers expected, those who died suddenly had higher rates of other cardiac risk factors, including obesity, hypertension, high cholesterol and more. But independent of these factors, those with the highest waist-to-hip ratio had more than double the risk of sudden cardiac death compared with those in the normal range. The increased risk was apparent only in nonsmokers."

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FDA Approves Blood Test That Gauges Heart Attack Risk – WebMD

Read the full article: FDA Approves Blood Test That Gauges Heart Attack Risk – WebMD:

"The U.S. Food and Drug Administration on Monday approved a new blood test that can help determine a person's future odds for heart attack and other heart troubles.

The test is designed for people with no history of heart disease, and it appears to be especially useful for women, and black women in particular, the agency said."

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Tuesday, December 9, 2014

Eager-to-please Indian manufacturers creating GMP chaos says expert - iPT

Read the full article: Eager-to-please Indian manufacturers creating GMP chaos says expert - iPT:

"The problem is “cultural,” said Shah, originally from India and now head of UK-based Sigma, speaking afterwards to in-Pharmatechnologist.com.

“The classic thing in India is these guys will never say no. You will say to them, ‘I need this done,’ and they’ll say ‘Of course.’”

The result is delays and frustration from buyers, he said."

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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