About

/About
About 2018-04-01T14:58:16+00:00

Meet the Editor-in-Chief

Barbara W. Unger

Meet industry veteran Barbara Unger. As the editor-in-chief of GMP Regulatory Intelligence and FDAzilla's GMP Quality Expert, she has been in your shoes.

Most recently, she was the Director of External Quality for Amgen. There, 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 GMP/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.

Let Barbara do the scanning, filtering, analysis, and synthesis for you.

FDAzilla

Since 2010, the FDAzilla platform has been utilized by hundreds of clients, ranging from Fortune 500 companies in every FDA-regulated industry, to law firms, to insurance companies and banks, and to consultants. Our data and analytics have been cited by major media outlets such as MSNBCWSJ, and the Boston Globe, and FDAzilla.com is viewed more than 1 million times per year.

The FDAzilla library is the most complete repository of FDA inspection data in existence. Our platform takes this unique data set and provides data analytics, benchmarking, monitoring services, and inspection documents. Equipped with this unrivaled information, FDAzilla customers can make better decisions and stay one step ahead of the FDA.

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