- TypeSeminar
- Location Philadelphia, Pennsylvania, United States
- Date 17-11-2016 - 18-11-2016
Education/Teaching/Training/Development
Manufacturing
OVERVIEW:
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. Examples from real processes and testing procedures will be used to present the student with examples that will be directly applicable to their work.
Why should you 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.
Who will benefit:
AGENDA:
Day 1 Schedule
Dietary Design of Experiments
Lecture 1: Introduction
                o Defining the CPP and CQA for a process
                o Defining the design space
Lecture 2:
One Level, One Factor Designs. Simple Comparisons.
               o The least significant difference (LSD)
Lecture 3:
Two-Level Multi-factorial Design
              o Conversion to the standard form with results of testing
Lecture 4:
Extracting Information from the Experiment
Day 2 Schedule
Statistical Process Control
Lecture 1:
Shewhart Charts for Variable Data
Lecture 2:
Shewhart Charts for Attribute Data Especially Counts.
             o Handling binomially distributed data.
             o Handling binomially distributed data.
Lecture 3: Considerations from Shewhart Charts
Lecture 4:
Other Types of Charts Related to Shewhart Charts
For more details and updates please visit website
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
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