Center for Professional Innovation & Education (CfPIE), Berlin, Germany
Dec. 5 & 6, 2011
This comprehensive course will be valuable to personnel evaluating stability of new chemical entities (NCEs), new molecular entities (NMEs), and formulations of brand and generic products. Course coverage includes small molecule, biologic and drug/device products for domestic and worldwide markets. Providing a step-by-step foundation for establishing product shelf life through stability testing, this course outlines the issues and guidelines surrounding requirements for global compliance, such as the Americas, EMEA and ASEAN regions, plus country-specific health authorities like the FDA. Additionally, guidance and mandates from ICH and WHO will be discussed in detail. This course will focus specifically on establishing a successful stability program through in-depth discussions on writing and revising stability protocols, stability sample management, stability indicating assays, out of specification (OOS) results, and deviations.
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