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