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. The work, however, is done by the development, manufacturing, or quality systems worker who should also attend this course to learn how to design the systems and studies, and interpret the results generated.
Dietary Design of Experiments
Day 1 – Agenda
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
Statistical Process Control
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
Who Will Benefit:
Lead workers in Process Development
Quality Assurance and Quality Control
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.
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.
Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.
DATE AND VENUE:
Location: Orange County CA | February 7th & 8th, 2013
Conference Timings: 9 am to 6 pm PST
WILL BE ANNOUNCED SOON
Price – $1,295.00
Toll free: 800-425-9409
USA, Livermore Common, Fremont,
CA 94539, USA Phone: 1800 425 9407