Center for Professional Innovation & Education, Inc., Los Angeles, CA
June 19 - 21, 2013
This landscape for biologic and biopharmaceutical products, coupled with ongoing changes in regulations and expectations, makes it extremely important for a company to have an effective QA/QC risk management strategy for each stage of drug development, from Phase 1 clinical trials through market approval. This course highlights the challenges and pressures facing QA/QC in today’s biologic and biopharmaceutical environment, and presents the strategic importance and value generated by QA/QC for their involvement in control of the manufacturing process, and testing and release of these products. QA/QC regulations and guidances from the U.S. FDA, EMEA and ICH are discussed in detail.
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