FDA Audit Preparation

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• FDA cGMP online training courses, programs, and classes offered by SkillsPlus International Inc.

The folks from Emergo Group have a very nice outline of how to think and approach FDA inspection readiness, before the FDA actually shows up at your door.

Preparation for an FDA Quality System Audit - from Emergo Group:

"In order to meet US Food and Drug Administration (FDA) requirements, medical device manufacturers active in the US market must undergo FDA audits of their quality management systems to demonstrate compliance with Quality System Regulation 21 CFR Part 820, also known as Good Manufacturing Practice (GMP)."

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Disaster Supplies and Preparedness Checklist

Image via WikipediaThere have been recent global earthquakes, floods, and storms.

I live in the San Francisco Bay Area of California, and I sense that we're due for an earthquake.

To that end, I'm sharing this checklist for all of us to start following, so that we can be fully prepared for whatever disaster comes our way:

Your Family Disaster Supplies and Preparedness Calendar (pdf)

Be safe, be well!

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Dietary Supplements - Tips for FDA Inspection

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If you're involved in the manufacturing of dietary supplements, you might find this article by Amy Caplette a helpful read, Inside a GMP Inspection.  She recounts her inspection experience and provides some tangible tips that you can follow before you get inspected.

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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.

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GMP Audit Checklist For Drug Manufacturers - ISPE

- - -  original post follows below  - - -

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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FDA Cosmetics GMP Inspection Checklist - Free

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

Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics

The FDA offers a Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for cosmetic establishment instructions, that are excerpted from the FDA's Inspection Operations Manual. The FDA checklist may serve as guidelines for effective self-inspection. According to the FDA, a good inspection score means that an establishment follows good manufacturing practice.

Previous Posts:
30 FDA GMP Compliance Tips
FDA Audit Preparation - Audit Theory - Be Ready

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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FDA Audit Preparation - Audit Theory - Be Ready

This Pharma Compliance Blog post, The Role of Affect in your Culture of Compliance, resonates with me. I think in principle, the core idea about being prepared for audits, extends well beyond GMP regulated industries. The takeaway for me is, of course your paperwork needs to be in order, AND your people have to prepped from an emotional and behavioral standpoint.

Related Posts:
21 CFR Part 820 QSR Audit Checklist - Are you ready?
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.

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SkillsPlus Intl Inc. - GMP Compliance Training Experts
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The Health, Drug, Prescription, and GMP Supersite Gift Store