Tuesday, October 6, 2015

Kopcha Selected to Head FDA’s Quality Office | Pharmaceutical Technology

Read the full article: Kopcha Selected to Head FDA’s Quality Office | Pharmaceutical Technology:

"Michael Kopcha, a pharma industry veteran with 25 years of experience in formulation and process development, process validation, technology transfer, off-shoring/outsourcing, and change management, has been named the permanent director of FDA’s Office of Pharmaceutical Quality (OPQ), according to a Sept. 25, 2015 announcement by Janet Woodcock, director, Center for Drug Evaluation and Research (CDER). Kopcha will join CDER in November pending ethics clearance.

FDA’s OPQ was launched in January 2015 to implement processes and policies to provide better alignment among review, inspection, and research functions."

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