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Press Release

2 Day Seminar: FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2017 in Review (San Diego, CA, United States - January 30-31, 2018) - Research and Markets

Research and Markets
Posted on: 05 Jan 18

The "FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2017 in Review" conference has been added to Research and Markets' offering

This hands-on seminar provides a comprehensive approach to learning how to proactively prevent non-compliance. There will be intensive reviews on the negative consequences of receiving regulatory enforcement actions. FDA Warning Letters are posted publicly on the CDER web site.

Your competitors, shareholders, the public and your patients now become aware of your shortfalls. Many Warning Letters today mandate the hiring of third party consultants, which can be quite expensive. An Injunction will require pharmaceutical companies to spend millions of dollars and require years until you bounce back. Multimillion disgorgement penalties are being levied along with Injunctions.

The FDA is increasing its enforcement actions both for domestic and foreign inspections. Enforcement statistics have not been summarized yet because 2017 has not ended yet. We are certainly seeing more Warning Letters and Import Alerts based on Data Integrity (21 CFR Part 11: Electronic Records; Electronic Signatures. In the past FDA used to issue several Warning Letters to the same firms upon consecutive inspections. Today, after receiving one Warning Letter the next regulatory action is elevated to Import Alert, Consent Decree, and Injunctions for domestic manufacturers.

FDA's Office of Manufacturing Quality (OMQ) at the Center for Drug Evaluation and Research (CDER) evaluates compliance with current Good Manufacturing Practice (cGMP) for drugs based on inspection reports and evidence gathered by FDA investigators. The office also develops and implements compliance policy and takes advisory actions to protect the public from adulterated drugs in the U.S. market.

Senior Management must take the initiative in setting the tone of full compliance:

  • Taking regulatory risks may no longer be worth the price of getting caught
  • Planned deviations cannot be used as an excuse for not following your written procedures
  • Retesting into compliance has been unacceptable for many years and will no longer be tolerated
  • Senior officials are being held responsible. Today, these Captains may go down with the ship - sent to prison and fined millions of dollars

For more information about this conference visit

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Last updated on: 05/01/2018

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