At the International GMP Conference held virtually in March 2022 and co-sponsored by the University of Georgia at Athens and FDA, FDA Office of Regulatory Affairs National Drug Expert Captain, Ileana Barreto-Pettit, presented in-depth case studies from recent drug GMP inspections that illustrate agency findings and concerns.

In a four-part series of articles, Redica Systems Senior GMP Quality Expert Jerry Chapman dove into each case study presented, including an in-depth analysis of the findings, lessons learned, and how companies can avoid similar shortcomings.

Areas examined in the case studies are:

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4 GMP Case Studies

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