Barbara Unger

Barbara Unger formed Unger Consulting, Inc. to provide GMP auditing and regulatory intelligence services to the pharmaceutical industry, including general GMP auditing and auditing and remediation in the area of data management and data integrity.

Her corporate auditing experience includes leadership of the Amgen corporate GMP audit group for APIs and quality systems. She also developed, implemented, and maintained the GMP regulatory intelligence program for eight years at Amgen.

This included surveillance, analysis, and communication of GMP related legislation, regulations, guidance, and industry compliance enforcement trends.

Barbara Unger was the first chairperson of the Rx-360 Monitoring and Reporting work group that summarized and published relevant GMP and supply chain related laws, regulations, and guidance.

In addition, she was previously co-lead of the Rx-360 Data Integrity Working Group.

She is author or co-author of the following chapters of GMP Compliance Adviser:

0.A.2 Nitrosamine impurities in medicines: What have we learned? – EMA report 2020
0.A.3 Unpacking FDA's new guidance on controlling nitrosamine impurities in drugs

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