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

Education

(Free Press Release) GlobalCompliancePanel, a leading regulatory and compliance training gateway, will host a two-day, in-person seminar on the topic, “Design of Experiments and Statistical Process Control for Process Development and Validation” on February 7 and 8 at Orange County, CA.

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


      

 

Course Agenda:

The soul of this this course is a presentation of the procedures that must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. Why this needs to be done is because the FDA has, in a recent guidance document on Process Validation assigned the responsibility for reviewing and interpreting DOE and SPC studies to the Quality Unit.

How to go about doing this work requires a practical orientation. It calls for an approach with case studies and examples. This seminar will fulfill this requirement. It will offer theoretical information introduced only when necessary to understand an experiment. A highly interactive and practical session; this seminar offers examples from real processes and testing procedures and present the participants with examples that will be directly applicable to their work.

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Course Description:

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

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Purpose of the seminar

Any pharmaceutical worker, who performs, supervises or reviews manufacturing or testing processes needs to understand the relationships among the process parameters. This knowledge should enable the worker to monitor the performance of processes and test methods.

This is particularly true for the worker in Quality Control and Quality Assurance, especially in the backdrop of the recent FDA guidance document on Process Validation that has assigned the responsibility for reviewing and interpreting DOE and SPC studies to the Quality Unit.

The actual work, however, is done by the development, manufacturing, or quality systems worker. This session will help such workersget a hands-on experience of how to design the systems and studies and interpret the results generated. It will offer them valuable assistance in how to actually get about their work of designing studies and systems. As a result of this learning, participants will be able to work on these aspects in accordance with FDA requirements.

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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.

During an impressive career spanning over 30 years, Steven has applied his academic knowledge to quality control in the pharmaceutical industry. Steven has written several papers and book chapters, and serves on the editorial advisory boards of BioPharm, BioQuality, and the Journal of GXP Compliance. He has held certifications as a CQA, CQT, and CQE from the American Society of Quality and was certified (RAC) by the Regulatory Affairs Professionals Society.

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Who will benefit:

o Directors

o Managers

o Supervisors

o Lead workers in Process Development

o Manufacturing

o Regulatory Affairs

o Quality Assurance and Quality Control

o 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.

DATE AND VENUE:

February 7 and 8, 2013

Seminar Timings: 9am to 6pm EST

Venue:Will be announced soon

Price –$ 1495;

Group discounts available in the following pattern:

Send two attendees: Get a discount of 10%

Send three to six attendees: Get a discount of 20%

Send seven to 10 attendees: Get a discount of 25%

Send 10 attendees or more: Get a discount of 30%

To avail the above group discounts, all the participants should register by making a single payment.Please contact Customer Care at 1800 447 9407

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Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884

Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Website:https://www.globalcompliancepanel.com/

GlobalCompliancePanel

NetZealous

USA Livermore Common, Fremont,

CA 94539, USA

Phone: 1800 425 9407

 




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

Source: Press Release

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