By Regina Fullin, Senior Compliance Consultant, Compliance Team, Inc. Companies who find themselves in the midst of an enforcement action (Warning Letter, Consent Decree or similar) are often operating in reaction mode. The goal, from the … Read More
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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
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
By Regina Fullin, Sr. Compliance and Validation Consultant, Compliance Team, Inc. Compliance is difficult when you “don’t know what you don’t know.” In other words, a clear understanding of the regulation you need to comply to is a … Read More