New Whitepaper: Key Strategies to Succeed at your Next FDA Inspection
We are all aware that the FDA is taking a much stronger position in the world of enforcement and inspection activity. While many of us have had good relationships with our District office over the years (and work hard to maintain those relationships) we should always make certain we are well prepared when the agents show up at our door. Maybe it’s time for a brief refresher with the latest whitepaper now available for download, "Key Strategies to Succeed at your Next FDA Inspection"
Written by frequent Quality Management 2.0 guest blogger Christine Park, this whitepaper is a great resource for your next FDA inspection. While many FDA inspections are scheduled with some advance notification, there is always a possibility that an inspector from the agency could show up at your door any time. When was the last time an inspector from the FDA showed up at your site? Are you prepared?
It is a standard practice to have a Standard Operating Procedure (SOP) defining what your organization should do when the FDA (or other government agency) shows up at your site. When was the last time your SOP was reviewed and updated? Are the key players the same?
In this whitepaper, we have compiled several document control resources related to hosting the FDA. It provides great generic guidance and reference for any industry, and includes:
- Which Specific Areas to Consider in your Standard Operating Procedure for FDA inspections
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Who a Subject Matter Expert Is, What They Do, and How to Select Them
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What a Proof Book is and Why You Need One for Document Control
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How to Survive the Backroom During an FDA Inspection
Click the button below to download the complete reference for FDA Inpections. This IBS America whitepaper is an excellent resource to start thinking about your organization's FDA quality plan and hosting strategy and the potentials and benefits of document control software.
About the Author: Christine (Chris) Park is a seasoned Quality Assurance professional with a wealth of experience in establishing and remediating quality systems of all sizes. Using a pragmatic approach to compliance and quality assurance, Ms. Park has successfully focused on results-oriented solutions that integrate quality into the daily business activities of organizations.
Ms. Park's direct experience includes facilitating product and process risk assessments, change management, product and process validation plans and protocols.
Cpark928@mindspring.com
678-480-5411