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.


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