2 Day Seminar: FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry – 2017 in Review (Chicago, IL, United States – March 29-30, 2018) – Research and Markets

DUBLIN–(BUSINESS WIRE)–The “FDA
Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry
– 2017 in Review”
conference has been added to ResearchAndMarkets.com’s
offering.

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.

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.

This year we have seen:

  • Increased use of Contract Manufacturing Organizations (CMO) has
    increased the regulatory focus on CMO and requirements for Quality
    Agreements are being enforced
  • There has been an increase in Warning Letters in 2017
  • An increase in Import Alerts enforcement actions
  • Data Integrity issues are being found more frequently

For more information about this conference visit https://www.researchandmarkets.com/research/9t49pq/2_day_seminar?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
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Related
Topics: Pharmaceuticals,
Drug
Discovery
, Pharmaceutical
Manufacturing