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After the FDA reorganization, it had appeared that the FDA’s focus came back to the standard issues. In this summary, we find newcomers to the standard list, and some departures. If the FDA is changing focus, there may now be a bit more bias toward Data Integrity. Complete the form below to[See More: Data Integrity]
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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 - Director of GxP Consulting - 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 performing an audit of … 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
by Regina Fullin, Compliance Consultant at Compliance Team, Inc. Counterfeit medication is a worldwide problem. Many of us in the United States may be surprised to realize that, in some countries, up to 70% of pharmaceutical products are … Read More