Jenny Gold reports that, "In fact, there are 40,000 medical applications available for download on smartphones and tablets — and the market is still in its infancy. But that growth is in the cross hairs of new regulatory efforts from the Food and Drug Administration."
FDA regulators face daunting task as health apps multiply – USATODAY.com:
"Franko's goal is to make sure doctors and patients know what they're getting as quickly as possible. "These apps already exist," he says, "and people are using them in hospitals to make medical decisions, but no one knows if they're actually doing what they claim to be doing.""
'via Blog this'
This is all about mobile, tablet, digital technologies intersecting the FDA's QSR regulations applicable to medical device manufacturers (i.e., 21 CFR 820).
You might also be interested in:
Essentials for Medical Device Manufacturers - Recommended QSR Training - SkillsPlus Intl Inc.
21 CFR 820 Essential Elements - The Best Online QSR Training - SkillsPlus Intl Inc.
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store
Showing posts with label 820. Show all posts
Showing posts with label 820. Show all posts
Saturday, June 23, 2012
FDA regulators face daunting task as health apps multiply
Wednesday, February 24, 2010
Another Free GXP Checklist!
- FDA GMP QSR cGMP Training. Popular online training courses by SkillsPlus Intl Inc.
Updated November 23, 2020
Link in the original post broke.
You might also be interested in:
- - - original post follows below - - -
It's another resource and perspective on approaching FDA GMP audit preparedness.
Additional Resources:
ISO 13485:2003 and FDA QSR (21 CFR 820) Internal Audit and Gap Analysis Checklist
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
SkillsPlus Intl Info Blog
Saturday, September 20, 2008
Free 21 CFR Part 820 QSR Audit Checklist
FDA Guide to Inspections of Quality Systems
Updated February 13, 2021
Some posts just don't age well (i.e., broken links below).
You might also be interested in:
FDA - Guide to Inspections of Quality Systems
- - - original post follows below - - -
Don't be caught flat-footed, be ready for the FDA. "Highlight any compliance gaps in your quality management system with a comprehensive FDA GMP Checklist...," says Chris Scholl Consulting Associates. On their site, they offer a free checklist, "21 CFR 820 Audit Checklist." If you don't know where or how to start, they suggest a couple of things to think about, "Are You Ready for the FDA?"
FDA - Guide to Inspections of Quality Systems
- - - original post follows below - - -
Don't be caught flat-footed, be ready for the FDA. "Highlight any compliance gaps in your quality management system with a comprehensive FDA GMP Checklist...," says Chris Scholl Consulting Associates. On their site, they offer a free checklist, "21 CFR 820 Audit Checklist." If you don't know where or how to start, they suggest a couple of things to think about, "Are You Ready for the FDA?"
You might also be interested in:
- This class prepares plant personnel to participate in an FDA Inspection.
SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Exemptee Institute
The Designated Representative Institute
The Health, Drug, Prescription, and GMP Supersite Gift Store
Subscribe to:
Posts (Atom)
Posts
