FDA - 21 CFR 820 - Mobile Optimized

Need a quick way to reference the FDA's 21 CFR 820 (Medical Device regulations)?

Then checkout this mobile optimized collection of these regs, in one of two ways:

1. Go to this link:  http://breadcrumb.googleusercontent.com/view?id=ag5nbGFiczIwLXBhdmxvdnIOCxIFU3RvcnkYlZm7AQw
2. Follow the QR code, in this post.

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

Free QSR Training (video)

• People also search for FDA CGMP Online Training - respected FDA GMP online training courses offered by SkillsPlus International Inc.

Updated April 13, 2021

The original links broke.

You'll also be interested in:

An Introduction to FDA's Regulation of Medical Devices - FDA.gov

PresentationExternal Link Disclaimer   Printable Slides   Transcript

---  the original post follows below  ---

According to the FDA, the quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements.

Checkout this free training offering by the FDA, Quality System Regulation 21 CFR Part 820 Basic Introduction (video).

Here's what you get with the complete course offering:

1. Quality System Regulation 21 CFR Part 820 Basic Introduction - Online Video Presentation (with Captioning)
2. Quality System Regulation 21 CFR Part 820 Basic Introduction - Printable Slide Presentation

You might also be interested in:

Essentials for Medical Device Manufacturers - a training class by SkillsPlus International Inc.

Teaches employees the essential elements of QSR for beginning work in the medical device industry

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

FDA Draft Guidance - Medical Device ISO - Voluntary Audit Report Submission Program

The Federal Register notice just announced the availability of the FDA Draft Guidance for Industry, Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program.

The medical device ISO 13485:2003 Voluntary Audit Report Submission Program outlined in this draft guidance is another way in which FDA may leverage audits performed by other Global Harmonization Task Force (GHTF) regulators and accredited third parties in order to assist the agency in setting risk-based inspectional priorities.

The FDA recommends that a domestic or foreign device manufacturer that is subject to the requirements in 21 CFR Part 820, Quality System (QS) regulation be eligible to participate in the ISO 13485:2003 Voluntary Audit Report Submission Program under certain circumstances described on the FDA webpage (link provided above).

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

Free FDA QSR Basic Intro Course In Spanish - Espanol

Kim Trautman of the FDA CDRH’s Division of Enforcement B, Office of Compliance, provides a basic FDA overview course on the Quality System Regulation covered in 21 CFR 820 in Spanish (free).

The course covers the material with spoken and written Spanish (Espanol).

Another fine offering from the FDA.

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

FDA Medical Device Online Courses In Chinese - Free

Here's more from the FDA's CDRH Learn treasure trove of free online courses. ... and these are in Mandarin Chinese! As of this posting, there's only one FDA CDRH Learn course in Mandarin, but you can expect more courses to be on their way. Here's what's available so far: Quality System Regulation 21 CFR Part 820 Basic Introduction Online Video Presentation Transcript 

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

FDA Medical Device Online Courses - Free

• Recommended FDA GMP online training courses and programs by SkillsPlus Intl Inc.

This is a great example of your government dollars working for you.

The FDA offers several free CDRH Learn online courses. These courses are intended for industry on safety and effectiveness of medical devices and exposure to radiation from medical devices.

Here's what's neat about the courses. Each course includes a captioned video, slide set, and post-test.

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

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

Medical Device Sponsors - FDA Trends and Tips To Avoid 483s

Updated November 5, 2024

The original link broke

You might also be interested in this article by the same author, Carl Anderson:

The FDA 483 - https://carl1anderson.wordpress.com/wp-content/uploads/2009/03/the-fda-483.pdf

---  the original post follows below  ---

The Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration, released inspection statistics for the 2007 fiscal year. The statistics for the 40 Bioresearch Monitoring (BIMO) inspections of medical device sponsors showed serious concerns for compliance with good clinical practice (GCP) regulations. Author Carl Anderson explains the CDRH findings, identifies problem areas to avoid, and gives tips on how to avoid 483s, in his article, "Trends in FDA CDRH Bioresearch Monitoring Inspections." The following are the topics he covers in the article . . .

• About the Division of Bioresearch Monitoring Organization at CDRH
• Medical Device Sponsor Inspections
• Quality Systems in Clinical Trials
• Implications of BIMO Inspection Statistics - with a top 5 category list of deficiencies

Don't get caught flat-footed. Reading this article will help you steer clear of choppy waters, warnings, and 483s.

Related Posts:
More FDA 483 Resources - Comments and Pearls from Validation Online
FDA 483 Inspectional Observations - learn from these examples

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

FDA QSR Human Factors Reqs - Intro

Updated April 17, 2019

The links in the original post broke.

You might also be interested in:
Human Factors and Medical Devices on FDA.gov

---  original post follows below  ---

OK, now I get it. I understand this topic quite a bit better after reading Human Factors MD's "FDA Human Factors Requirements." This is applicable for medical devices that need to follow the FDA's regulations on Do It By Design: An Introduction to Human Factors in Medical Devices and Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. Even better, the folks at Human Factor's MD, cite section 820.30 of the QSR, in paragraphs c, f, and g, and walk us through the meaning and application of those paragraphs. Did you find it helpful too? These three paragraphs cover . . .

• design input
• design verification
• design validation

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

6 Free FDA QSR Design Controls Tutorials

• FDA cGMP QSR GMP Training - online training courses by SkillsPlus International Inc.

Updated November 22, 2020

All the links broke in the original post.

You might also be interested in:

Design Controls (presentation slides) - FDA.gov

Design Controls - on FDA.gov

- - -  original post follows below  - - -

ODDS Company describes itself as an "educational and consulting company that deals with product and process improvements at all levels (from Executive Management to engineering support staff). ODDSCO is particularly useful to medical device manufacturer organizations that always must remain auditably compliant with FDA 21 CFR 820, the Quality System Regulation."

The ODDSCO website offers 6 free tutorials for this reason, "unless basic knowledge of any claimed area of expertise is understood, the value of offered consulting and training services will not be apparent and likelihood of sales is small. But, if the free basic training is perceived as useful and indicative of consultant's knowledge, that likelihood improves. In other words, when equipped with the basic knowledge, a visitor whose organization desires to virtually automate effective QSR Design Controls compliant medical devices development with minimal resources and schedule impact could become a highly qualified customer or client."

The Six (6) Free Tutorials (go to the ODDSCO site for amplified descriptions):
1. Automating FDA QSR Design Controls Compliance
2. Integrated Product/Process Team, Concurrent Engineering, and Systems Engineering
3. The Continuous Improvement Process (CIP) and Total Quality Management (TQM)
4. Knowledge Support Systems (KSS) and Tools
5. An IPPT Supporting Decision Process
6. Project Risk Assessment

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

Home Medical Testing Kits - Overview and Recommendations (video)

 I really like this MSNBC video, "Medical Testing At Home." It provides an introduction to home testing and includes some important tips, such as:

• Read the label and instructions carefully
• Use only FDA-approved tests
• Follow all instructions
• Keep good testing records
• Call the 800 number for questions

I was surprised by the breadth of tests available, for example, blood pressure, blood sugar, drugs of abuse, cholesterol, fertility, etc. In some cases, brand recommendations are made.

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

Free 21 CFR Part 820 QSR Audit Checklist

• FDA GMP Online Training - popular CGMP online training courses offered by SkillsPlus International Inc.

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?"

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

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