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CTI Articles

Managing Your Compliance Risk 

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

Serialization Made Simple

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

Executive Summary: The Drug Supply Chain Security Act

By: Regina Fullin, Sr. Compliance/Validation Consultant, Compliance Team, Inc. Drug companies and the FDA have an image problem.  Many instances of adulterated prescription drugs make it to the market, be they stolen goods, counterfeit goods, or … Read More

Keys to Compliance Success for UDI and Serialization

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

Track and Trace Status Update

By Regina Fullin, Compliance Team Senior Compliance/Validation Consultant On November 27, 2013, President Obama signed the FDA’s Drug Supply Chain Security Act (DCSA) into law.  This law specifies a number of milestones to enhance the integrity … Read More

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