Overview: The number of replicates chosen for a particular measurement or observation has a direct bearing on the statistical strength of the resulting conclusion. The number depends upon the nature of the information required and the level of risk that the experimenter is willing to accept. It is also dependent upon the level of uncertainty present in the system. This webinar will cover the considerations necessary for making the calculations needed to determine the number of replicates needed for the determination of various statistical parameters with a given level of risk. Areas Covered in the Session: Calculating the replicates needed for averages and confidence intervals The case of variances and standard deviations. The replicates needed when meeting specifications. What are the "p" values? Who Will Benefit: The webinar is designed to provide the introductory information that a QC or manufacturing worker needs in order to understand the number of replicates that must be collected for various studies. Regulatory Affairs personnel who prepare the CMC sections of submissions. Development personnel who will set the early specifications. R & D personnel who will contribute data for use in development. Project managers for product development studies. Quality systems auditors Consultants. Steven 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. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . Price: $245.00 USA GlobalCompliancePanel, Livermore Common, Fremont, CA, 94539 USA Phone:800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com