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Global Compliance Panal
Discovery
GMP Expectations for Products Used in Early Phase IND StudiesGlobal CompliancePanel Webinar Areas Covered in the Session: * Discussion of the elements found in the guidance document for Phase 1 material. * What to do at really early stages. * What about special IND studies? * What about preclinical studies? * Varying GMP activities that depend upon the nature of the IND product. * What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act? * What to do about QC activities such as instrument qualification, method validation, and process validation. |
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