Q&A: CDER Official Offers Tips on GMP Inspections

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).

Mr. Evans, whose FDA experience includes 17 years as an inspector, provides insights on issues commonly encountered by companies seeking FDA compliance. Cindy Fazzi, MasterControl copywriter and editor, conducted the interview by phone.