Editor’s note: KR Karu will be the guest on Quality Digest Live this Friday, June 22, 2012, at 11 a.m. Pacific.

Recently, Janet Woodcock, M.D., the director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA), criticized the pharmaceutical industry’s lack of commitment to quality management during a presentation at a joint FDA and International Society for Pharmaceutical Engineering (ISPE) meeting in Baltimore. “Pharmaceutical quality management is lacking, and we are not anywhere near where we need to be,” she said. “The whole mantra of the quality revolution is to meet customers’ needs, and that drives everything.”

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