21 CFR Part 820 QSR Audit Checklist - Are you ready?

Updated June 3, 2020

The original post didn't age well.

You might also be interested in this 21 CFR 820 Audit Checklist found on SCRIBD:
https://www.scribd.com/doc/162185575/122763962-Audit-Checklist-9001-13485-21-cfr-820

- - -  original post follows below  - - -

If you're not quite ready, or are in the process of putting together your own internal audit checklist, it's a good idea to get ideas from others. Get a feel for checklist content, organization, and layout. Look at this excerpted portion of a checklist from Jack Kanholm's book (ISO 13485 and FDA QSR Internal Audit Checklist): ISO 13485:2003 Internal Audit Checklist - Demo Download.

Related Posts:
Free 21 CFR Part 820 QSR Audit Checklist

- - - 

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

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:

Our most popular course

Put fun back into GMP training!

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors

You Eat Too Much Salt!!!!

People, stop eating so much salt, says this CDC post, "Americans Consume Too Much Salt - Lower sodium recommendation applies to almost 70 percent of American adults." Here's what you need to know . . . This study is the first to use national data to show that 69.2 percent of the adult population belongs to a specific group that should aim to consume no more than 1,500 mg of sodium per day. This group includes persons with high blood pressure, blacks, or middle-aged and older adults (more than 40 years old). The 2005 Dietary Guidelines for Americans recommend that adults in general should consume less than 2,300 mg (approximately one teaspoon of salt) of sodium per day. Can you cut back on your salt?! 

Return Home: http://drughealth.blogspot.com/ 

Drug Identity Resources - ID Numbers

Updated February 23, 2021

There can never be too many resources available to help identify drug, pill, or medication identity by using various descriptors such as ID numbers and more. Here's a bunch for your use and reference . . .

Free Online Drug Identity Resources:

Drugs.com Pill Identification Wizard

RXList Advanced Search

 

Free Governmental Medication Resources:

Drugs@FDA

National Drug Code Directory

Electronic Orange Book 

Return Home: http://drughealth.blogspot.com/

FDA Must Consider Dropping Age Limit For Morning After Pill

The FDA let politics cloud its judgment when it denied teenage girls over-the-counter access to the Plan B morning-after pill, a federal judge said Monday as he ordered the FDA to let 17-year-olds obtain the medication. The judge ruled the agency had improperly bowed to political pressure from the Bush Administration when it set 18 as the age limit in 2006. U.S. District Judge Edward R. Korman in New York instructed the agency to make Plan B available to 17-year-olds within 30 days and to review whether to make the emergency contraceptive available to all ages without a doctor's order, reports this Washington Post news article, "FDA Ordered to Rethink Age Restriction for Plan B - Judge Says Politics Influenced Policy on the Contraceptive." What a polarizing firestorm this is going to create! What do you think?! 

Return Home: http://drughealth.blogspot.com/ 

Chronic Pain - Vital Role of Vitamin D (video)

Updated September 9, 2020

The links in the original post broke.

You might also be interested in this updated link:

Mayo Clinic study suggests those who have chronic pain may need to assess vitamin D status

- - -  original blog post follows below  - - -

Mayo Clinic research shows a correlation between inadequate vitamin D levels and the amount of narcotic medication taken by patients who have chronic pain. This study found that patients who required narcotic pain medication, and who also had inadequate levels of vitamin D, were taking much higher doses of pain medication -- nearly twice as much -- as those who had adequate levels. Similarly, these patients self-reported worse physical functioning and worse overall health perception. "This is an important finding as we continue to investigate the causes of chronic pain," says Michael Turner, M.D., a physical medicine and rehabilitation physician at Mayo Clinic and lead author of the study.

Watch this short video of Dr. Turner as he describes his findings about vitamin D and chronic pain. Tip: you might need to scroll down the page to the video.

Related Posts:
Starting Methadone? It could kill you - You must read this!
FDA Warns - Avoid Burning - MRI and Drug Patch Interaction

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store