Barbara W. Unger

/Barbara W. Unger

About Barbara W. Unger

Barbara formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, I led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. I developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function. I was the first chairperson of the Rx-360 Monitoring and Reporting work group (2009-2014) that summarized and published summaries of relevant GMP and supply chain related laws, regulations and guidance. Currently I co-chair the data integrity working group within Rx-360. I also served as the chairperson of the Midwest Discussion Group GMP-Intelligence sub-group from 2010-2014. I received a bachelor's degree in chemistry from the University of Illinois in Urbana, Illinois. Barbara W. Unger Unger Consulting Inc. www.ungerconsulting.net 805.217.9360

Week of November 11th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

This week the FDA posted 4 new warning letters. One was issued to a cell/tissue product manufacturer, 1 to a firm for failure to list, 1 to a compounding pharmacy, and 1 to a device manufacturer. We cover 3 of these in this post.