Overview: FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1. 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.Who Will Benefit: Regulatory Affairs personnel who coordinate activities for the CMC sections of submissions.QA/QC personnel who need to plan work on early stage materialR & D personnel who will contribute data to CMC sections.Project managers for product development studies.Quality systems auditorsConsultantsSteven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. GlobalCompliancePanel Phone: 800-447-9407Fax: 302-288-6884