THIS COURSE WILL PRESENT THE PROCEDURES THAT MUST 2013 - 2-day In-person Seminar on Statistical Process Control for Process Development and Validation Philadelphia

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Category Medical Device, Pharma, Biotech, Clinical, Drug, Food Safety, Heath,FDA

Deadline: May 23, 2013 | Date: May 24, 2013-May 25, 2013

Venue/Country: California, U.S.A

Updated: 2013-04-02 16:24:13 (GMT+9)

Call For Papers - CFP

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.

Course Outline:

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

Statistical Process Control

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:

? Directors

? Managers

? Supervisors

? Lead workers in Process Development

? Manufacturing

? 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.

About 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.

Steve has participated in the development of drugs and biological through all phases of clinical research and final product production.

DATE, VENUE & PRICE:

Location: Philadelphia, PA | May 23rd & 24th, 2013 (Thursday & Friday) | 9 AM to 6 PM EDT

Venue: Double Tree by Hilton Hotel Philadelphia Center City

Price: $1,295.00

Register now and save $200. (Early Bird)

Until March 29, Early Bird Price: $1,295.00

From March 30 to May 21, Regular Price: $1,495.00

Contact Information:

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