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33275 Conferences

Design of Experiments and Statistical Process Control for Process Development and Validation 2017

Added by globalcompliancepanel on 2017-09-06

Conference Dates:

Start Date Start Date: 2017-11-16
Last Date Last Day: 2017-11-17
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2017-11-14

Conference Contact Info:

Contact Person Contact Person: Event Manager
Email Email:
Address Address: Kuala Lumpur, Kuala Lumpur, Malaysia
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

Course "Design of Experiments and Statistical Process Control for Process Development and Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


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 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.

Who will benefit:

Lead workers in Process Development
Regulatory Affairs
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.

Day 1 Schedule

Dietary Design of Experiments
Lecture 1:
Input/Output, CPP and CQA, what are they?
o Defining the CPP and CQA for a process
o Defining the design space
Snedecor's F-test and ANOVA
Lecture 2:
One Level, One Factor Designs. Simple Comparisons.
The simplest form of the full F-test.
A one factor ANOVA with multiple treatments
o The least significant difference (LSD)
The use of blocking in a one factor experiment.
Lecture 3:
Two-Level Multi-factorial Design
Description of the experiment
o Conversion to the standard form with results of testing
Definition of an Orthogonal Array
Interactions in the array
Effects (Contrasts) in the array.
Lecture 4:
Extracting Information from the Experiment
Use of a Half-normal Plot.
What about the second set of test data?
Using the effects for a Pareto Chart
Interpreting the interactions for process design

Day 2 Schedule

Statistical Process Control

Lecture 1:
Shewhart Charts for Variable Data
Classical X-bar and R-bar charts
Estimating control limits for early studies
Significance of events using the "Western Electric Rules."
Lecture 2:
Shewhart Charts for Attribute Data Especially Counts.
p and np charts for attributes.
o Handling binomially distributed data.
c charts and u charts for non-conformities
o Handling binomially distributed data.
Lecture 3:
Considerations from Shewhart Charts
Rational subgroups.
Setting the process capability indices.
Coupling as a problem
Lecture 4:
Other Types of Charts Related to Shewhart Charts
Moving average chart
Exponentially weighted chart
CUSUM chart


Dr. Steven Kuwahara
Founder & Principal, GXP Biotechnology, LLC

Dr. Steven 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.

Location: Kuala Lumpur, Malaysia Date: November 16th & 17th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON , Kuala Lumpur, Malaysia

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