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Download the Top 483’s of 2018
In 2017, the FDA made big changes, with Program Alignment, which, in turn, led to a short-term spike in the number of 483s issued during 2017. The rate of 483s issued has since normalized in 2018, but that doesn’t mean the FDA is any less focused on key areas.
Complete the form below see the Top 483’s of 2018 and learn more about what the FDA has focused on during 2018.
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Graphic courtesy of Searchquotes.com By Regina Fullin, Director of Compliance Consulting Services, Compliance Team, Inc. People talk all the time about New Year’s Resolutions, but it seems like people make the same resolutions over and over. The … Read More
By Regina Fullin, Director of Compliance Consulting Services at Compliance Team, Inc. After looking at over 6 months of data, here's What Warning Letters Reveal about Data Integrity What Warning Letters Reveal about Data Integrity - In 2015, … Read More
User Requirement Specifications (URS) and Design Qualification (DQ) are implemented in many organizations in response to EU and other guidance documents. Many organizations lack understanding of why these tools are recommended and therefore … Read More
If you ask a pharmaceutical professional about the FDA’s requirements for medical devices, the answer you might get is a vague nod to the understanding that medical device regulations are “less restrictive” than pharmaceutical regulations. What are … Read More
By: Regina Fullin Sr. Compliance/Validation Consultant Compliance Team Inc. Gaining understanding of your organization’s compliance risk can be challenging. It seems like regulators choose a different area of focus each time when … Read More
The NIPP will revolutionize the way the FDA manages pharmaceutical inspections. This article will describe the framework of this initiative, and what it is intended to achieve. In 2015, the FDA announced its five Strategic Priorities for 2015 … Read More