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:

GMP Audit Checklist For Drug Manufacturers - ISPE

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Checkout this free checklist made available by the Auditing Group, Inc., Audit Checklist for Drug Industry.

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

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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
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FDA CFR Title 21 Database Search Page - Excellent!

Initially, I wasn't too thrilled about the FDA website getting re-designed. Now I'm starting to like what I'm seeing. For example, I'm seeing more user friendly pages like the CFR Search page. If you don't have the Search CFR Title 21 Database page bookmarked, you really should. It's a terrific database search tool for finding CFR contents by:

• Section number
• Part number
• Full text search

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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

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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

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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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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!

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New Medicare Plan Search Tool - Joppel

Updated March 24, 2024

The original link broke.

You might also find this useful:

Explore your Medicare coverage options - Medicare.gov

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Choosing the right plan can be very challenging. Try this newly released tool by Joppel. It's a free tool designed to search Medicare Advantage, Medicare Prescription Drug (Part D) and Medicare Supplement (Medigap) health plans simultaneously from all insurance carriers to match consumers to the plan that fits their coverage needs. It can be so confusing out there, so having access to free tools like this is really wonderful.

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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

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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

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21 CFR Part 110 - cGMPs for Food - free online

Get your money's worth for your tax dollars. The FDA publishes these food regulations online on their FDA website, and they're available for free! I'm posting these because of the recent tomato and pepper Salmonella scare, and my recent post on the 'fruitcake of the Shuttle astronauts' FDA warning letter. Here's what you get from the FDA . . .

NOTE:
When you open any of the links below, be sure to look at the upper left portion of the page to see the revision date.

Title 21 -- Food and Drugs
Chapter 1 -- Food and Drug Adminstration
Department of Health and Human Services

SubChapter B -- Food for Human Consumption
Part 110
CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

Subpart A--General Provisions
§ 110.3 - Definitions.
§ 110.5 - Current good manufacturing practice.
§ 110.10 - Personnel.
§ 110.19 - Exclusions.

Subpart B--Buildings and Facilities
§ 110.20 - Plant and grounds.
§ 110.35 - Sanitary operations.
§ 110.37 - Sanitary facilities and controls.

Subpart C--Equipment
§ 110.40 - Equipment and utensils.

Subpart D [Reserved]

Subpart E--Production and Process Controls
§ 110.80 - Processes and controls.
§ 110.93 - Warehousing and distribution.

Subpart F [Reserved]

Subpart G--Defect Action Levels
§ 110.110 - Natural or unavoidable defects in food for human use that present no health hazard.

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