FDA Mandates Shocking Cigarette Smoking Images (video)

Beginning September 2012, FDA will require larger, more prominent cigarette health warnings on all cigarette packaging and advertisements in the United States, FDA Cigarette Health Warnings.

They're very much in your face, and on some gut level, pretty shocking, as this video shows:





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How To Pass An FDA Audit - More Free Tips

More free tips on how to prepare and pass an FDA audit, from Arena Solutions, 5 Tips to Pass Your FDA or ISO Audit with Confidence.

In a nutshell:

1. Document Your Standard Operating Procedures (SOPs)
2. Train Your People
3. Control, Track, and Manage Your Data Electronically
4. Audit Yourself
5. Have the Proof at Your Fingertips

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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Portable Swimming Pools Pose A Danger

Summer started and I'm sweltering.  I work in Pleasanton, CA, and the last two days there have baked as high or near 100 degrees.  ... wishing I had that in-ground or portable swimming pool to cool down.

My mind wanders, as I also have family in New Mexico, and they have an above ground pool with a little one running around.

In the heat of Summer, and in pursuit of watery cool, the danger of portable swimming pool lurks, reports this Pediatrics journal article, Pediatric Submersion Events in Portable - Above-Ground Pools in the United States, 2001–2009.

In a nutshell, the authors conclude that there's a risk:

". . .especially in the under 5-year-old age group. No single strategy will prevent all submersion deaths and injuries; therefore, layers of protection are recommended. Industry is advised to engage in development of protective devices that are effective and affordable for portable pools, including isolation fencing, pool alarms, and safety covers"

Please folks, be thoughtful, wary, and careful this Summer.

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Related articles

• Young Child Drowns in Grandmom's Swimming Pool - cnbnews.net (gloucestercitynews.net)
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• Child Drowns in Portable Pool Every 5 Days (newser.com)
• Toddler Found Face Down In Swimming Pool Rescued By Cousin (newyork.cbslocal.com)

Free Tips On Preparing For An FDA Inspection

Here's a good article from Bruce McDuffee, Tips on Preparing for an FDA Inspection - Are you following current good manufacturing practices?

References he mentions:
FDA form 482
Investigations Operations Manual (IOM)

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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Related articles

• FDA Inspections: Insights into Responding to FDA Inspectional Observations (life-sciences.blognotions.com)
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Tell Stories . . . - Free GMP Training Tip

GMP Labeling's Spring 2011 Newsletter is a good read:

Using Stories, Anecdotes, and Metaphors to Make your GMP Training Come Alive (pdf) - By David C. Markovitz

Lots of good ideas!

You might also be interested in:
The Adult Learner, Sixth Edition: The Definitive Classic in Adult Education and Human Resource Development

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We Mobile-Optimized This Blog

Image via Wikipedia

This blog is now mobile optimized!

With any luck, if you're viewing this on a mobile device, you'll see a mobile-optimized version of this blog.  If you don't like it, you'll see a link for "View web version."

Thanks for stopping by!

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GMP Training - Tack It Onto Employee Safety Training

This FDA GMP training idea comes from David C. Markovitz in a training tip sheet entitled, GMP and Safety - Employee Safety and Customer Safety (pdf).

Here are my takeaways:

1. Take advantage of a captive audience by delivering GMP training to staff attending regularly scheduled safety meetings.
2. Start with employee safety and end with customer safety (GMP).

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Weekend Hospitalizations Could Be Bad For Your Health

Not the kind of news we want to hear, as reported by this Medpage Today synopsis, Weekend Admission May Raise Risk of Death.

In summary, the study authors conclude:

"These data demonstrate significantly worse outcomes after nonelective admission during the weekend compared with weekdays. Although the underlying mechanism of this finding is unknown, it is likely that factors such as differences in hospital staffing and services offered during the weekend compared with weekdays are causal and mutable."

Try to stay out of the hospital this weekend!

Reference:  Arch Surg. 2011;146(5):545-551. doi:10.1001/archsurg.2011.106

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• Weekend the deadliest time in intensive care (theage.com.au)
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