Top 5 Key Take-Aways from FDA and EU GMP Drug Enforcement Actions

 

The GMP landscape continues to evolve quickly for drug companies.  Now is a good time as any to look back at the last 12 months.

What did GMP-related warning letters focus on in 2014?  What kind of companies are getting hit the hardest?  What did GMP-related drug recalls focus on?  What about the class I recalls? What new issues did the inaugural year of the Eudra GMDP bring to the landscape?  What changes to the EU GMP guide is most relevant for us?

Get the answers to these questions and more with the FDAzilla 2014 REGULATORY REVIEW REPORT.

We don’t fluff up this report with marketing or the typical useless charts that just take up real estate. This is a dense, concise 7-page report (with supporting links) that gives you broad context for these 5 key take-aways.  That context comes from decades of experience doing these annual retrospectives over and over again from our GMP subject matter expert, Barbara Unger.

Barbara UngerBarbara Unger is editor-in-chief of GMP Regulatory Intelligence and also President of Unger Consulting, Inc. Most recently, she was the Director of External Quality for Amgen where she designed, developed, implemented, and managed a sophisticated and comprehensive GMP Regulatory Intelligence program for 8 years. A key part of that program was surveillance of the environment on a daily basis and communication of time-sensitive and business-critical information to relevant management and staff in real time. Her newsletter inside Amgen was distributed broadly across the company – from VPs to front-line quality, operations, development and regulatory personnel.

Barbara has also been an industry leader in the area of GMP Regulatory Intelligence. Barbara was a leader in Rx-360, the pharmaceutical and device global supply chain consortium founded in 2009. She was the founding chairperson for the Monitoring and Reporting team that identified and published summaries of new and revised GMP and GDP laws, regulations and guidance that impacted the pharmaceutical and device industries. She led the group from its inception in 2009 through 2014. She was chairperson of the GMP Intelligence subgroup of the Midwest Discussion Group from 2010-2014.

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