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Follow on Google News | 2-day In-person Seminar on “Statistical Process Control for Process Development and Validation”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.
At its core, this seminar is about the procedures that must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. During this interactive session that will be informative and fun; the speaker will familiarize participants with the nuances of this subject. He will adapt a practical approach studded with case studies and examples,and will offer theoretical information introduced only when it is necessary to understand an experiment. Dr. Kuwahara will demonstrate several examples from real processes and testing procedures during the session. The aim is to help participants associate themselves with examples that will be directly applicable to their work. For any pharmaceutical worker who performs, supervises or reviews manufacturing or testing processes, an understanding of the relationships among the process parameters and the ability to monitor the performance of processes and test methods are necessary. This is all the truer of the worker in Quality Control and Quality Assurance, since a recent FDA guidance document on Process Validation has assigned the responsibility for reviewing and interpreting DOE and SPC studies to the Quality Unit. This work, however, is done by the development, manufacturing, or quality systems worker. So, synchrony between these two levels of employees is needed. This course will equip these two levels of employees with the knowledge of how to design the systems and studies, and interpret the results generated. ------------------------------------------------------------ About the Speaker: 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. After securing degrees in Biochemistry from Cornell and the University of Wisconsin, Steven started off as an Assistant Professor of Chemistry. His testing skills were honed in the initial years of his career at the Division of Biologic Products at the Michigan Department of Public Health (now BioPort Corp.), where he became the head of Quality Control. Here, he developed expertise in the testing of blood derivatives, viral and bacterial vaccines. His work has also dealt with all aspects of GMP and GLP in relation to biopharmaceuticals. He has worked with small molecules, proteins, cells, and gene therapy vectors. ------------------------------------------------------------ The agenda: The seminar will have the following agenda: Day 1 –Agenda Dietary Design of Experiments Lecture 1: Introduction Lecture 2: One Level, One-Factor Designs Simple Comparisons Lecture 3: Two-Level Multi-factorial Design Lecture 4: Extracting Information from the Experiment Day 2 –Agenda Lecture 5: Shewhart Charts for Variable Data Lecture 6: Shewhart Charts for Attribute Data Especially Counts. Lecture 7: Considerations from Shewhart Charts Lecture 8: Other Types of Charts Related to Shewhart Charts ------------------------------------------------------------ For whom: This seminar will benefit: a. Directors b. Managers c. Supervisors d. Lead workers in Process Development e. Manufacturing professionals f. Regulatory Affairs professionals g. Quality Assurance and Quality Control professionals h. Workers who will be participating in operations or the supervision of the development, manufacturing, or testing of medicinal products will benefit from knowing the procedures and applications of DOE and SPC. ------------------------------------------------------------ About GlobalCompliancePanel: GlobalCompliancePanel (GCP) is a specialized offering from NetZealous LLC, a Technology and Business Process Solutions and Services Company registered in Fremont, CA. It is a fountainhead for Continuous Professional Education, compliance training and consulting. GCP offers a broad range of high quality regulatory and compliance-related services relating to Medical Devices, Pharmaceutical, FDA, Food, PCI industries, and SOX. Some of the Governing Areas its webinars cover are GxP (Manufacturing/ These seminars are an extension of online trainings, at which GCP has conducted around 700 webinars since inception on a variety of topics for these industries /verticals. More than 30,000 professionals have benefited from these trainings. GlobalCompliancePanel’ This is the next in a series of regulatory and compliance related seminars that GlobalCompliancePanel has been organizing all over the US. Its previous seminars have met with resounding success. GlobalCompliancePanel’ ------------------------------------------------------------ Venue, date and timings: The venue for this seminar is the DoubleTree by Hilton Hotel Philadelphia Center City237 South Broad Street, Philadelphia, Pennsylvania, 19107-5686. The seminar will be on May 23 and 24, from 9 A.M to 6 P.M PDT. ------------------------------------------------------------ Price: $1,495.00 per participant. Discounts are available for group participation in the following manner: For two attendees: 10% discount For three to six attendees: 20% discount For seven to 10 attendees: 25% discount For more than 10 attendees: 30% discount To avail the above group discounts, all the participants should register by making a single payment. Please note that the registration will be closed two days (48 hours) prior to the start date of the seminar. Call our representative on 1800 447 9407 to have your seats confirmed. End
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