COURSE "STATISTICS FOR QUALITY CONTROL AND PROCESS 2013 - Statistics for Quality Control and Process Validation: Basic Factorial Designs - Webinar By GlobalCompliancePanel

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

Deadline: March 14, 2013 | Date: March 14, 2013

Venue/Country: California, U.S.A

Updated: 2013-03-11 19:07:36 (GMT+9)

Call For Papers - CFP

The webinar will be based on a single two-level, three-factor experiment whose design will be explained, and its results analyzed using several methods to test the validity of our conclusions. The linking of Critical Process Parameters (CPP) to Critical Quality Attributes (CQA) will be described.

Areas Covered in the Session:

The simplest designed experiment and its superiority over an OFAT study.

Description of a 3-factor, 2-level design.

Use of coding and the standard order.

Calculating effects (contrasts)

Looking for interactions

Testing the effects with a half-normal plot.

Relating CPP to CQA

Who Will Benefit: By raising the level of complexity to a two-level, three-factor study, the QC and manufacturing worker will now be introduced to designed experiments. A single processing study will be used to provide examples for the design and analysis of an experiment.

Regulatory Affairs personnel who prepare the CMC sections of submissions.

Development personnel who will set the early specifications.

R & D personnel who will contribute data for use in development.

Project managers for product development studies.

Quality systems auditors

Consultants.

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.

USA

GlobalCompliancePanel,

Livermore Common, Fremont, CA, 94539

USA Phone:800-447-9407

Fax: 302-288-6884

webinarsglobalcompliancepanel.com

http://www.globalcompliancepanel.com

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