RAPS pre-approved webinar on "Statistics for Quality Control and Process Validation: Statistical Process Control (SPC) for Attribu

A test method or manufacturing process does not end with validation. There is a continuing need to demonstrate that the procedure continues to operate consistently and reproducibly in a manner that meets the validation requirements.

Fremont, CA (prHWY.com) March 21, 2013 - Description:
A test method or manufacturing process does not end with validation. There is a continuing need to demonstrate that the procedure continues to operate consistently and reproducibly in a manner that meets the validation requirements.

Continuous process verification is an FDA expectation too. This is demonstrated in the recent guidance document on process validation. The FDA wants to see continuous process verification employed over the working life of a test method or manufacturing process. The way to achieve this is through the use of Statistical Process Control (SPC) charting, which has for long been recognized as a method for monitoring processes of all types.
This webinar will discuss the application of basic SPC to attribute data and will present the rules used in the interpretation of the charts.
It will cover the following areas:
o SPC charts based on simple counts of attributes. Conversion into a variables chart.
o Binomial Data and Distribution
o SPC chart for binomial data
o SPC chart for counts following the Poisson Distribution
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When:April 11, 12:30 AM PDT | 3:30 PM EDT
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By whom:
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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For whom:
The webinar will benefit
o Regulatory Affairs personnel who prepare the CMC sections of submissions.
o Development personnel who will set the early specifications.
o R & D personnel who will contribute data for use in development.
o Project managers for product development studies.
o Quality systems auditors
o Consultants
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Duration: 90 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407

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Tag Words: pharmaceutical training, regulatory compliance, fda training, medical device training, pharmaceutical compliance, compliance training

Categories: Health

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