Register for the Webinar

5 Ways to Avoid FDA Labeling Fines


With numerous drug compliance programs in effect at the FDA and all around the world, navigating labeling compliance can be daunting. When labeling processes are not properly managed, mistakes can result in fines, penalties, and even criminal charges.

Ben England and Bill Nychis of FDAImports.com will discuss how the label is the very first place the FDA looks when scouting for compliance violations. For API (Active Pharmaceutical Ingredients) shipments entering the U.S., and at each following checkpoint, the FDA targets pharmaceutical packages with inadequate or incorrect labeling.

Register Today!
Date: Thursday, October 22, 2015
Time: 1:00 PM - 2:00 PM EDT

Join this webinar for answers to these questions:

  1. Labeling is critical for drug manufacturing—what are the key distribution check points?
  2. How can you avoid labeling causing FDA non-compliance
  3. How do labels need to be properly updated at each step in the process, including cautionary statements, Rx declarations and intended use?
  4. How can labeling exemptions be leveraged to avoid violations and drive business efficiencies?
  5. How can an enterprise labeling solution help pharmaceutical companies avoid many FDA labeling violations, counterfeiting and grey market diversion?

Learn how enterprise labeling can support many of the challenges facing pharmaceutical companies today, including: security, workflows, ERP integration, eSignatures, business rules, reporting and much more. A centralized, integrated enterprise labeling solution can greatly improve label accuracy and regulatory compliance for complex, global pharmaceutical supply chains.