For this article, MasterControl Inc., a leading software provider for life sciences and other regulated industries, interviews Kristen Evans, senior regulatory operations officer at the office of Compliance of the FDA's Center for Drug Evaluation and Research (CDER). During the interview they discuss good manufacturing practice (GMP) inspections.
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Mr. Evans, whose FDA experience includes 17 years as an inspector, provides insights on issues commonly encountered by companies seeking wanting to prepare for a GMP inspection.
For more information about GMP inspections, please feel free to contact a MasterControl representative.