THIS WEBINAR WILL DISCUSS THE APPLICATION OF BASIC 2013 - Statistics for Quality Control and Process Validation: Statistical Process Control (SPC) for Variable Data - Webinar By GlobalCompliancePanel

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

Deadline: April 11, 2013 | Date: April 11, 2013

Venue/Country: California, U.S.A

Updated: 2013-03-20 15:52:41 (GMT+9)

Call For Papers - CFP

The recent guidance document on process validation has indicated that the Food and Drug Administration is expecting to see continuous process verification employed over the working life of a test method or manufacturing process. Statistical Process Control (SPC) charting has long been recognized as a method for monitoring processes of all types. This webinar will discuss the application of basic SPC to variable data, and present the rules used in the interpretation of the charts.

Areas Covered in the Session:

Background on the use of SPC charts. Walter Shewhart and his ideas.

The standard SPC chart for variables.

A common variant of the standard chart

The Western Electric Rules for SPC charting.

Who Will Benefit: The webinar is designed to provide the introductory information that a QC or manufacturing worker needs in order to understand the methods for monitoring the conformance to process specifications.

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. 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 .

USA

GlobalCompliancePanel,

Livermore Common, Fremont, CA, 94539

USA Phone:800-447-9407

Fax: 302-288-6884

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