Overview:Examples from real processes and testing procedures will be used to present the student with examples that will be directly applicable to their work. This course will present the procedures that must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. A practical approach with case studies and examples will be used, with theoretical information introduced only when necessary to understand an experiment.Why you should attend:Any pharmaceutical worker who performs, supervises or reviews manufacturing or testing processes needs to understand the relationships among the process parameters and be able to monitor the performance of processes and test methods. This is particularly true for the worker in Quality Control and Quality Assurance as the recent FDA guidance document on Process Validation has assigned the responsibility for reviewing and interpreting DOE and SPC studies to the Quality Unit.Course Outline:Dietary Design of ExperimentsDay 1 – AgendaLecture 1: IntroductionLecture 2: One Level, One Factor Designs. Simple Comparisons. Lecture 3: Two-Level Multi-factorial DesignLecture 4: Extracting Information from the ExperimentStatistical Process ControlDay 2 – AgendaLecture 5: Shewhart Charts for Variable DataLecture 6: Shewhart Charts for Attribute Data Especially Counts.Lecture 7: Considerations from Shewhart ChartsLecture 8: Other Types of Charts Related to Shewhart ChartsWho Will Benefit:DirectorsManagersSupervisorsLead workers in Process DevelopmentManufacturingRegulatory AffairsQuality Assurance and Quality ControlABPUT SPEAKER:Dr. 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.